generated: '2026-08-02'
method: searched
source: https://reflexion.com/legal/compliance-declaration/
summary: 'RefleXion Medical is a medical device manufacturer with no published API
  surface, so no API/interface standards apply. What the company does publish is a
  healthcare-industry compliance declaration and FDA device clearances, recorded here
  as the real, evidenced conformance posture.'
standards:
- id: oig-compliance-program-guidance
  name: OIG Compliance Program Guidance for Pharmaceutical Manufacturers (HHS Office
    of Inspector General)
  conforms: true
  evidence: 'Compliance declaration states the program is modeled on the OIG Compliance
    Program Guidance for Pharmaceutical Manufacturers'
  source: https://reflexion.com/legal/compliance-declaration/
- id: advamed-code-of-ethics
  name: AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals
    (June 1, 2022)
  conforms: true
  evidence: 'Compliance declaration states adherence to the AdvaMed Code of Ethics
    (June 1, 2022 edition)'
  source: https://reflexion.com/legal/compliance-declaration/
- id: california-health-safety-code-119400
  name: California Health & Safety Code sections 119400-119402
  conforms: true
  evidence: 'Compliance declaration asserts compliance and publishes the annual $75.00
    spending cap on hospitality, promotional and educational items for California health
    care professionals'
  source: https://reflexion.com/legal/compliance-declaration/
- id: fda-510k-clearance
  name: US FDA 510(k) clearance
  conforms: true
  evidence: 'RefleXion X1 cleared for SRS, SBRT and IMRT in 2020; SCINTIX biology-guided
    radiotherapy cleared 2023-02-02 for tumors in the lung or bone'
  source: https://reflexion.com/our-company/
- id: fda-breakthrough-device-designation
  name: US FDA Breakthrough Device Designation
  conforms: true
  evidence: 'Breakthrough Device Designation granted in 2022 for biology-guided radiotherapy
    targeting lung tumors'
  source: https://reflexion.com/our-company/
- id: iso-13485
  name: ISO 13485 medical device quality management systems
  conforms: null
  evidence: 'Not published on the public site; not asserted either way'
- id: oauth2
  conforms: false
  evidence: 'No public API, no securitySchemes, no OAuth documentation found'
- id: openid-connect
  conforms: false
  evidence: '/.well-known/openid-configuration returned 404 on reflexion.com'
- id: rfc9457-problem-details
  conforms: false
  evidence: 'No OpenAPI or error contract published'
- id: rfc9116-security-txt
  conforms: false
  evidence: '/.well-known/security.txt returned 404 on reflexion.com'
- id: fhir-r4
  conforms: false
  evidence: 'No FHIR endpoint, resource shapes or documentation found; RefleXion is
    a therapy-delivery device manufacturer, not a health-data platform'
x-evidence:
  fetched: '2026-08-02'
  urls:
  - https://reflexion.com/legal/compliance-declaration/
  - https://reflexion.com/our-company/
  - https://reflexion.com/.well-known/security.txt
  - https://reflexion.com/.well-known/openid-configuration