generated: '2026-08-04'
method: searched
source: https://www.paige.ai/ai-technology-and-services
note: >-
  Paige is a regulated medical-device company, so its published conformance posture
  is regulatory and information-security, not API-protocol. No OpenAPI, AsyncAPI, GraphQL
  SDL or MCP manifest is publicly available for the Paige Platform / UnifAI API, so
  no API-protocol standard (OAuth 2.0, OIDC, RFC 9457, JSON:API, FHIR, DICOMweb) can
  be asserted from evidence — each is recorded as unknown rather than false.
standards:
- id: iso-13485
  conforms: true
  category: quality-management
  evidence: 'Paige states it is ISO 13485 certified (medical-device QMS) on https://www.paige.ai/ai-technology-and-services'
- id: iso-27001
  conforms: true
  category: information-security
  evidence: 'Paige states it is ISO 27001 certified on https://www.paige.ai/ai-technology-and-services'
- id: hipaa
  conforms: true
  category: healthcare-privacy
  evidence: 'Paige states HIPAA compliance on https://www.paige.ai/ai-technology-and-services'
- id: gdpr
  conforms: true
  category: data-protection
  evidence: 'Paige states GDPR compliance on https://www.paige.ai/ai-technology-and-services'
- id: gxp
  conforms: true
  category: life-sciences-quality
  evidence: 'Paige states GxP compliance on https://www.paige.ai/ai-technology-and-services'
- id: fda-de-novo
  conforms: true
  category: regulatory
  evidence: >-
    Paige Prostate received FDA De Novo authorization in September 2021 — the first
    AI-based pathology product authorized by FDA.
    https://www.paige.ai/press-releases
- id: fda-510k
  conforms: true
  category: regulatory
  evidence: >-
    FullFocus whole-slide-image viewer cleared by FDA 510(k) for primary diagnosis
    (2020). https://www.paige.ai/diagnostic-ai
- id: ce-ivd
  conforms: true
  category: regulatory
  evidence: 'Paige states 12 CE-IVD marks for its digital-pathology AI algorithms on https://www.paige.ai/ai-technology-and-services'
- id: ukca
  conforms: true
  category: regulatory
  evidence: 'Paige states 12 UKCA marks alongside its CE-IVD marks on https://www.paige.ai/ai-technology-and-services'
- id: oauth2
  conforms: unknown
  category: api-security
  evidence: 'No public OpenAPI or auth documentation; docs.paige.ai returns Cloudflare error 1014 (probed 2026-08-04).'
- id: openapi
  conforms: unknown
  category: api-description
  evidence: >-
    No OpenAPI/Swagger document found at any Paige host. app.paige.ai answers 200 with
    an SPA HTML shell for every path including /openapi.json, /swagger.json and /api-docs
    (probed 2026-08-04) — not a spec.
- id: rfc9457-problem-details
  conforms: unknown
  category: api-errors
  evidence: No public API error reference.
- id: rfc9116-security-txt
  conforms: false
  category: disclosure
  evidence: 'https://www.paige.ai/.well-known/security.txt returns HTTP 404 with body {"message":"security.txt not found"} (probed 2026-08-04).'
x-evidence:
  fetched: '2026-08-04'
  url: https://www.paige.ai/ai-technology-and-services
  http_status: 200