Nines Trust Center

aid: nines-trust-center
name: Nines / Sirona Medical Trust Center
description: >-
  Named certifications and compliance programs for the platform that carries the
  former Nines AI radiology technology. Nines was acquired by Sirona Medical in
  February 2022; its FDA-cleared algorithms now run inside Sirona's RadOS
  platform. Certifications below are Sirona Medical's published claims.
generated: '2026-07-20'
method: searched
source:
- https://sironamedical.com/solutions/security-regulatory-compliance
- https://sironamedical.com/llms.txt
trust_center:
  url: https://sironamedical.com/solutions/security-regulatory-compliance
  operator: Sirona Medical
  lineage: >-
    Nines (teleradiology + AI, founded 2017, backed by Accel and 8VC) had its
    AI technology and key personnel acquired by Sirona Medical on 2022-02-18.
certifications:
- name: SOC 2 Type II
  status: certified
  detail: >-
    Six consecutive years with zero exceptions; independently audited annually
    across security, availability, processing integrity, confidentiality, and
    privacy.
- name: HIPAA
  status: compliant
  detail: HIPAA-compliant by design (encryption, audit logging, access controls, patient authentication).
- name: FDA Class I
  status: registered
  detail: >-
    Only FDA Class I reporter platform in radiology; regulated design-controlled
    SDLC. Includes the FDA-cleared NinesAI Emergent Triage and NinesMeasure
    algorithms acquired from Nines.
- name: ISO 13485
  status: in-progress
  detail: Pursuing certification; targeted for 2027 international expansion.
- name: EU MDR
  status: in-progress
  detail: Pursuing certification; targeted for 2027 international expansion.