generated: '2026-08-02'
method: searched
source: https://api.fda.gov/device/510k.json?search=applicant:%22anumana%22
docs: https://anumana.ai/ecg-ai-indications-for-use/
summary: >-
  Anumana is a regulated medical-device manufacturer, not a public API platform. Its
  conformance surface is therefore regulatory (FDA 510(k) device clearances) and clinical
  data-exchange (HL7 / DICOM / XML waveform ingestion inside the customer environment),
  not API-protocol conformance. No OpenAPI, GraphQL, AsyncAPI or MCP contract is published,
  so the usual protocol standards below are recorded as not-asserted rather than failed.
standards:
- id: fda-510k
  conforms: true
  evidence: 'Six Traditional 510(k) clearances held by Anumana, Inc. in the FDA device
    database (openFDA). See conformance/anumana-fda-510k.json for the verbatim response.'
  clearances:
  - k_number: K250652
    decision_date: '2025-07-28'
    device_name: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
    product_code: QYE
  - k_number: K253801
    decision_date: '2026-04-07'
    device_name: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
    product_code: SHP
  - k_number: K252360
    decision_date: '2026-03-28'
    device_name: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
    product_code: SAT
  - k_number: K260300
    decision_date: '2026-06-15'
    device_name: WatchMate Software
    product_code: QIH
  - k_number: K233160
    decision_date: '2023-11-25'
    device_name: NeuTrace EP Mapping System v.2.1
    product_code: DQK
  - k_number: K232699
    decision_date: '2023-09-28'
    device_name: Low Ejection Fraction AI-ECG Algorithm
    product_code: QYE
- id: hipaa
  conforms: true
  evidence: 'Anumana processes protected health information (12-lead ECG waveforms and
    patient results) as a US clinical software vendor deployed inside covered-entity
    environments; a Vanta-hosted trust center is published at https://trust.anumana.ai/.
    Certification detail behind the trust center is gated and was not readable anonymously.'
  qualifier: asserted-by-context; specific attestation reports not publicly readable
- id: hl7-v2
  conforms: true
  evidence: 'Vendor integration material describes configuration of HL7 datapoints so
    ECG-AI results flow into the customer EHR.'
  qualifier: documented in vendor integration material; no conformance profile published
- id: dicom
  conforms: true
  evidence: 'Digital waveform files are supported in XML and DICOM formats for automated
    processing by the ECG-AI framework.'
  qualifier: documented in vendor integration material; no DICOM conformance statement
    located
- id: fhir
  conforms: false
  evidence: No FHIR resource, capability statement, or FHIR-based integration surface
    was located on any Anumana host.
- id: openapi
  conforms: false
  evidence: 'Probed /openapi.json, /openapi.yaml, /swagger.json, /v1/openapi.json,
    /api-docs, /docs, /redoc on anumana.ai (all 404) and api.anumana.ai (every path 302s
    to /auth/signin/). No OpenAPI document is published.'
- id: graphql
  conforms: false
  evidence: /graphql returns 404 on anumana.ai and an auth redirect on api.anumana.ai.
- id: asyncapi
  conforms: false
  evidence: No event, streaming, or webhook surface is published. Not penalized - there
    is no event surface to describe.
- id: oauth2
  conforms: false
  evidence: /.well-known/oauth-authorization-server and /.well-known/oauth-protected-resource
    return 404 on anumana.ai and an auth redirect on api.anumana.ai.
- id: oidc
  conforms: false
  evidence: /.well-known/openid-configuration returns 404 on anumana.ai and an auth
    redirect on api.anumana.ai.
- id: rfc9457-problem-details
  conforms: false
  evidence: No public API responses are observable to classify.
- id: rfc9116-security-txt
  conforms: false
  evidence: '/.well-known/security.txt returns 404. A coordinated vulnerability disclosure
    policy is published as HTML at https://anumana.ai/vulnerability-disclosure/ instead.'
- id: a2a
  conforms: false
  evidence: /.well-known/agent-card.json and /.well-known/agent.json return 404 on
    anumana.ai; api.anumana.ai answers every path with an auth redirect. No agent card.