{"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"device_risk_lookup","title":"Review Device Category Risk Signals","description":"Review a medical-device category's public FDA signals by three-letter product code (e.g. FRN = infusion pump). Returns recalls, MAUDE adverse-event trend, warning-letter matches, a normalized category signal, its driver contributions, and interpretation limits. It does not predict enforcement against a firm.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"product_code":{"type":"string","minLength":3,"maxLength":3,"description":"FDA product code, e.g. FRN"}},"required":["product_code"]},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Review Device Category Risk Signals","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"firm_compliance_history","title":"Review Firm Compliance History","description":"Build a recent, source-bounded FDA public-record timeline for a device firm: matched recalls, warning letters, and Form 483 citations where exact FEI numbers are available. Product codes are discovered from Constat's AI/ML-device corpus or may be supplied explicitly. Returns attribution and coverage limits with the records; it is not a finding of noncompliance or a prediction of FDA action.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"firm_name":{"type":"string","minLength":2,"maxLength":160,"description":"FDA applicant or company name, e.g. 'Medtronic'"},"product_codes":{"description":"Optional FDA product-code scope. When omitted, Constat discovers codes from applicant matches in its device corpus.","maxItems":8,"type":"array","items":{"type":"string","minLength":3,"maxLength":3}},"fei_numbers":{"description":"Optional exact FDA FEI numbers; improves Form 483 attribution.","maxItems":20,"type":"array","items":{"type":"string","pattern":"^\\d{6,12}$"}},"since":{"description":"Earliest event date, YYYY-MM-DD. Defaults to five years ago.","type":"string","pattern":"^\\d{4}-\\d{2}-\\d{2}$"},"limit":{"description":"Maximum records per source and events in the timeline (default 50).","type":"integer","minimum":1,"maximum":100}},"required":["firm_name"]},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Review Firm Compliance History","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"watchlist_diff","title":"Poll Watchlist Changes","description":"Return machine-generated FDA public-record changes detected for monitored product codes since a caller-supplied date, plus each code's latest category snapshot and postmarket coverage. Defaults to Constat Radar's five-code watchlist and the last seven days. Analyst verdict text and internal review status are excluded; use next_since as the next polling cursor.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"product_codes":{"description":"FDA product codes to poll. Omit for the default Radar watchlist.","maxItems":20,"type":"array","items":{"type":"string","minLength":3,"maxLength":3}},"since":{"description":"Return changes on or after this ISO date or UTC timestamp. Defaults to the last seven days; pass the prior response's next_since for exact polling.","type":"string","pattern":"^\\d{4}-\\d{2}-\\d{2}(?:T\\d{2}:\\d{2}:\\d{2}(?:\\.\\d{1,3})?Z)?$"},"limit":{"description":"Maximum changes to return (default 100).","type":"integer","minimum":1,"maximum":200}}},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Poll Watchlist Changes","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"device_evidence_lookup","title":"Look Up Device Evidence","description":"Look up the structured premarket evidence FDA accepted for a specific AI/ML-enabled device by 510(k) number (e.g. K252148). Returns parsed summary fields — validation study design, sample sizes, endpoints, reported performance, predicate chain, PCCP — each with a verbatim source quote and page. Null means the summary did not state it.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"k_number":{"type":"string","pattern":"^(K|DEN)\\d{6}$","description":"510(k) or De Novo number, e.g. K252148 or DEN180001"}},"required":["k_number"]},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Look Up Device Evidence","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"evidence_search","title":"Search Device Evidence","description":"Find AI/ML device clearances by filter — product code, panel, applicant, and whether the submission reported clinical data, any sensitivity metric, or a PCCP. Answers 'what evidence did FDA accept for devices like mine'. Returns matching records with their parsed evidence. Presence flags are descriptive: 'reports a sensitivity metric' is not 'reports a comparable sensitivity' — analysis units differ across devices.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"product_code":{"description":"FDA product code, e.g. QAS","type":"string","minLength":3,"maxLength":3},"panel":{"description":"Advisory panel, e.g. Radiology","type":"string"},"applicant":{"description":"Substring match on applicant/company name","type":"string"},"has_clinical_data":{"type":"boolean"},"reports_any_sensitivity_metric":{"description":"Reported any sensitivity metric (canonical — includes per-finding sensitivities, not just the top-level slot). Not a claim of cross-device comparability.","type":"boolean"},"has_pccp":{"description":"Included a Predetermined Change Control Plan","type":"boolean"},"limit":{"type":"integer","minimum":1,"maximum":200}}},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{"type":"object","properties":{"count":{"type":"integer","minimum":0,"maximum":9007199254740991},"results":{"type":"array","items":{}}},"required":["count","results"],"additionalProperties":false},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Search Device Evidence","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"predicate_chain","title":"Trace Predicate Chain","description":"Trace the predicate ancestry of a 510(k) device, with each cited predicate's age (how many years old the predicate was when the child cleared). Reveals how AI/ML devices chain to older predicates.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"k_number":{"type":"string","pattern":"^(K|DEN)\\d{6}$","description":"510(k) or De Novo number, e.g. K252148 or DEN180001"},"depth":{"description":"Max ancestry depth (default 4)","type":"integer","minimum":1,"maximum":6}},"required":["k_number"]},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{"type":"object","properties":{"root":{"type":"string"},"chain":{"type":"array","items":{}}},"required":["root","chain"],"additionalProperties":false},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Trace Predicate Chain","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"evidence_cohort_stats","title":"Summarize Evidence Cohort","description":"Reporting-rate stats across the parsed AI/ML corpus (optionally by panel). Each rate is a presence figure with its denominator — 'reported in X of Y audited devices' — never a pooled performance value. Excludes not-yet-parsed devices from every denominator and discloses the parse queue separately. Predicate age (median years between a clearance and its cited predicates) is included when decision-date coverage clears a 60% floor, and withheld otherwise.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"panel":{"description":"Advisory panel, e.g. Radiology; omit for all","type":"string"}}},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Summarize Evidence Cohort","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"device_postmarket_lookup","title":"Look Up Device Postmarket Signals","description":"Post-clearance intelligence for one AI/ML device by 510(k) number: its product code's recalls, MAUDE adverse-event level and trend, warning-letter and 483 matches for the applicant, plus per-device drift signals (adverse-event inflection, re-clearances of the same device line, software-recall patterns, predicate-cohort recall activity). Descriptive observables with sources — never a safety judgment.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"k_number":{"type":"string","pattern":"^(K|DEN)\\d{6}$","description":"510(k) or De Novo number, e.g. K252148 or DEN180001"}},"required":["k_number"]},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Look Up Device Postmarket Signals","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"postmarket_search","title":"Search Postmarket Signals","description":"Find AI/ML devices by postmarket criteria — product code, panel, applicant, whether any drift signal exists, minimum recalls in 24 months, or a rising MAUDE trend. 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Returns every payment mechanism (NTAP add-on, Category I/III CPT + CMS rate, HCPCS, MAC LCD) with amounts, effective dates, and source links, plus any commercial/MAC payer coverage policies that reference the clearance or its codes. Answers 'who got paid, how much, through which mechanism, on what basis.' CPT codes are bare factual identifiers only — no procedure descriptors; follow the CMS source link for the official descriptor.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"k_number":{"description":"FDA clearance number, e.g. DEN170073 or K252148","type":"string","pattern":"^(K|DEN)\\d{6}$"},"cpt_code":{"description":"Bare CPT code, e.g. 75580 or 0932T","type":"string","pattern":"^\\d{4,5}[A-Z]?$"}}},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Look Up Reimbursement Pathways","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"reimbursement_search","title":"Search Reimbursement Pathways","description":"Find AI/ML device payment pathways by mechanism — e.g. 'devices that got NTAP', 'devices paid under a Category I CPT code', 'pathways with a known CMS dollar rate'. Filters: mechanism, CPT category, NTAP status, applicant. Returns pathways with amounts, effective dates, and sources. Use reimbursement_stats for the mechanism distribution (never a single pooled reimbursement rate).","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"mechanism":{"description":"Payment mechanism","type":"string","enum":["ntap","cat_iii_apc","cat_i","hcpcs","lcd","none"]},"cpt_category":{"description":"CPT category","type":"string","enum":["I","III","unknown"]},"ntap_status":{"type":"string","enum":["active","expired","granted","none"]},"applicant":{"description":"Substring match on device maker / applicant name","type":"string"},"has_cms_rate":{"description":"Only pathways with a known CMS dollar rate","type":"boolean"},"limit":{"type":"integer","minimum":1,"maximum":200}}},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{"type":"object","properties":{"count":{"type":"integer","minimum":0,"maximum":9007199254740991},"results":{"type":"array","items":{}}},"required":["count","results"],"additionalProperties":false},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Search Reimbursement Pathways","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"reimbursement_stats","title":"Summarize Reimbursement Cohort","description":"Distribution of payment mechanisms across the AI/ML reimbursement corpus — pathway and distinct-device counts per mechanism (NTAP, Cat I, Cat III/APC, …) with the min/median/max dollar amounts for each. Deliberately never a single pooled 'reimbursement rate': NTAP add-on amounts and CMS rates are different measurements and are reported separately with their own spreads.","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{}},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Summarize Reimbursement Cohort","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}} {"product":"Constat","track":"Radar","registry_id":"com.healthai/radar","endpoint":"https://constat.dev/api/mcp","server_version":"0.5.3","observed_at":"2026-07-30T03:24:30Z","name":"vehicle_risk_lookup","title":"Look Up Vehicle Safety History","description":"Look up NHTSA safety history for a vehicle by make, model, and model year. Returns recall campaigns and complaint statistics (crashes, fires, injuries, top components).","input_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"make":{"type":"string","minLength":2,"description":"e.g. honda"},"model":{"type":"string","minLength":1,"description":"e.g. civic"},"year":{"type":"string","pattern":"^\\d{4}$","description":"model year, e.g. 2020"}},"required":["make","model","year"]},"output_schema":{"$schema":"http://json-schema.org/draft-07/schema#","type":"object","properties":{"status":{"type":"string","enum":["ok","not_found","invalid_request","unavailable"]},"data":{"anyOf":[{},{"type":"null"}]},"message":{"type":"string"}},"required":["status","data"],"additionalProperties":false},"annotations":{"title":"Look Up Vehicle Safety History","readOnlyHint":false,"destructiveHint":false,"openWorldHint":false}}