servers / 483-risk-radar-by-health-ai

483 Risk Radar by Health AI MCP server

communitystreamable_httpremoteunknownhealthy

FDA device & vehicle recall risk for AI agents: recall history, MAUDE trend, risk score.

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01Tools · 14

How to read this: tool names here are observed from a live tools/list handshake. The Risk label is a heuristic inferred from the tool name (write/destructive verbs), not from executing the tool — a conservative guess, not a verified capability. We never escalate risk from a description. Found one that's wrong? Tell us — we fix on report.

Tool	Risk	Side effects	Approval
reimbursement_stats 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.	unknown	unknown	unknown
device_evidence_lookup 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.	read	false	unknown
cohort_postmarket_stats Postmarket presence rates across the snapshotted AI/ML device cohort (optionally by panel): share with any recall in 24 months, with a rising MAUDE trend, with any drift signal, with a warning-letter match — every rate with its denominator inline, never pooled across devices.	unknown	unknown	unknown
evidence_cohort_stats 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.	unknown	unknown	unknown
vehicle_risk_lookup 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).	read	false	unknown
reimbursement_lookup Trace the clearance-to-payment pathway for an AI/ML device by FDA clearance number (K/DEN, e.g. DEN170073) OR bare CPT code (e.g. 75580). 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.	read	false	unknown
device_postmarket_lookup 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.	read	false	unknown
device_risk_lookup 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.	read	false	unknown
predicate_chain 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.	unknown	unknown	unknown
firm_compliance_history 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.	read	false	unknown
watchlist_diff 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.	read	false	unknown
evidence_search 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.	read	false	unknown
postmarket_search 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. Returns per-device postmarket summaries with drift-signal counts.	read	false	unknown
reimbursement_search 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).	read	false	unknown

02Install & source

https://radar.healthai.com/api/mcp

remote_url

homepagehttps://radar.healthai.com/api/mcp

03Access granted

Knowledge & memory · writeProcess payments · write

The access this server can exercise, inferred from its verified tools — not a declared OAuth scope.

05Provenance & freshness

sourcesOfficial MCP Registry [p1]

last_checked2026-08-23 03:50Z

next_check2026-08-25 03:45Z

cadenceevery 48h

verifiedtools_list:passed handshake:passed metadata:failed tools_list:passed handshake:passed metadata:failed tools_list:passed handshake:passed metadata:failed tools_list:passed

index_statusindex — 5 unique facts >= 5

06Badge

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