generated: '2026-09-02'
method: searched
source: >-
  https://www.vektormedical.com/vmap plus the openFDA 510(k) device API
  (https://api.fda.gov/device/510k.json?search=applicant:%22Vektor%20Medical%22)
note: >-
  Vektor Medical publishes no API and therefore no API-standards conformance surface.
  What it does publish, and what is captured here, is medical-device regulatory
  clearance. The API/interop rows below are all conforms:false with an explicit
  "no contract published" evidence string — they are recorded as verified absences so a
  reader can tell the difference between "not checked" and "checked, nothing there".

conformance:

# --- Regulatory clearances (REAL, third-party verifiable) ---
- id: fda-510k
  name: FDA 510(k) premarket notification
  conforms: true
  evidence: >-
    Two clearances on record with FDA for applicant "Vektor Medical, Inc.", product code
    DQK, device "Vektor Computational ECG Mapping System (vMap)": K211546 decided
    2021-11-09 and K252429 decided 2025-12-04. Verified against the openFDA 510(k) API,
    not a marketing claim.
  identifiers:
  - K211546
  - K252429
  product_code: DQK
  source: https://api.fda.gov/device/510k.json?search=applicant:%22Vektor%20Medical%22

- id: ce-mark-eu-mdr
  name: CE Mark (EU Medical Device Regulation)
  conforms: true
  evidence: >-
    Vektor Medical's own vMap product page states vMap is "FDA-cleared for commercial use
    in the U.S. and CE marked for use in the EU" and "FDA-cleared and CE marked for nine
    arrhythmia and pacing types". The company announced the CE Mark in October 2025.
  source: https://www.vektormedical.com/vmap

- id: samd
  name: Software as a Medical Device (IMDRF SaMD)
  conforms: true
  evidence: >-
    vMap is regulated and marketed as standalone software that analyzes 12-lead ECG data
    and produces 2D/3D cardiac source maps; the December 2025 clearance describes its
    conversion into a Software as a Medical Device.
  source: https://www.vektormedical.com/vmap

# --- Healthcare interoperability standards: probed, absent ---
- id: hl7-fhir
  name: HL7 FHIR
  conforms: false
  evidence: >-
    No FHIR capability statement, resource endpoint, or FHIR claim appears anywhere on
    vektormedical.com. No /metadata or FHIR base URL exists on any resolvable host.
- id: hl7v2
  name: HL7 v2 messaging
  conforms: false
  evidence: >-
    No HL7 v2 message types, interface specification, or integration guide is published.
    Device connectivity is described in press material only, with no public contract.
- id: dicom
  name: DICOM
  conforms: false
  evidence: No DICOM conformance statement is published on the company site.

# --- Cross-cutting API standards: probed, absent (no contract to assert them against) ---
- id: oauth2
  name: OAuth 2.0
  conforms: false
  evidence: No public authorization server; /.well-known/oauth-authorization-server 404s.
- id: oidc
  name: OpenID Connect
  conforms: false
  evidence: /.well-known/openid-configuration returns 404 on www.vektormedical.com.
- id: openapi
  name: OpenAPI
  conforms: false
  evidence: >-
    No OpenAPI/Swagger document at any probed location on any Vektor Medical host
    (STEP 0b contract discovery — all candidates 404).
- id: rfc9457
  name: RFC 9457 Problem Details
  conforms: false
  evidence: No API contract published, so no error envelope to evaluate.

# --- Domain standard signature (0.12.0 domain_standard_conformance) ---
domain_standard:
  market: cardiac electrophysiology / diagnostic medical devices
  candidates_checked:
  - HL7 FHIR
  - HL7 v2
  - DICOM
  - IEEE 11073 (personal health device communication)
  declared_in_contract: false
  evidence: >-
    REWARD-ONLY check, not satisfied and not penalised. There is no machine-readable
    contract in which a domain standard could be declared. The regulatory clearances above
    are real and verified but are device clearances, not a contract-declared data standard.

compliance_certifications:
  published: false
  checked:
  - SOC 2
  - ISO 27001
  - HIPAA
  - PCI DSS
  - FedRAMP
  evidence: >-
    The privacy policy (last updated 2025-07-11) names none of these; it describes only
    generic "administrative, technical, and physical safeguards ... encryption, firewalls,
    secure server environments, and access controls". No trust center exists at
    trust.vektormedical.com (NXDOMAIN).
  source: https://www.vektormedical.com/privacypolicy