generated: '2026-07-21'
method: searched
source: https://screenpoint-medical.com/security-reporting
standards:
- id: iso-27001
  conforms: aligned
  evidence: 'Security program stated as aligned with ISO/IEC 27001 standards on the
    security-reporting page (not a certification claim).'
- id: fda-510k
  conforms: true
  evidence: 'Transpara FDA cleared (K241831, K232096) for 2D and 3D mammography.'
- id: ce-mark
  conforms: true
  evidence: 'Transpara CE marked (0344) for 2D and 3D mammography.'