Imaging & Diagnostic AI · Assurance Record
Aidoc aiOS
Aidoc · Hospital radiology · Cloud + on-prem hybrid
Decision summary
- Suitable for
- Health systems, radiology groups
- Documentary gate
- Failed
- Scenario match
- Matches this scenario — FDA-cleared imaging AI platforms
- Comparability
- Not yet comparable in this scenario
- Decision readiness
- HISTORICAL — Research only
- Documented evidence
- 0 of 3 evidence claims independently confirmed · confidence Low
- Critical unknowns
- No critical documentary gaps identified
- Last independent review
- not yet measured
independent reportMultiple FDA 510(k) clearances listed on the FDA AI-enabled medical device list for triage algorithms (ICH, PE, C-spine, AA).2026-03-27
Exact claim. Multiple FDA 510(k) clearances listed on the FDA AI-enabled medical device list for triage algorithms (ICH, PE, C-spine, AA).
- Source
- fda.gov
- Type
- independent report
- Published
- 2026-03-27
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- trust_governance
- Score contribution
- Feeds trust governance
Independent source. Methodology and sample vary by report; read the underlying method.
Open fda.govpeer reviewed studyReal-world performance evaluation of the Aidoc Medical Briefcase ICH Triage model across 101,944 non-contrast head CT examinations from 74,1…2025-12-24
Exact claim. Real-world performance evaluation of the Aidoc Medical Briefcase ICH Triage model across 101,944 non-contrast head CT examinations from 74,142 patients in a 17-facility academic health system (April 2023-April 2025) demonstrated 82.2% sensitivity, 97.6% specificity, and 96.6% accuracy for intracranial hemorrhage detection (npj Digital Medicine).
- Source
- pmc.ncbi.nlm.nih.gov
- Type
- peer reviewed study
- Published
- 2025-12-24
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Peer-reviewed. Check population, setting, and applicability to your workflow before generalizing.
Open pmc.ncbi.nlm.nih.govpeer reviewed studyMeta-analysis of six retrospective real-world studies encompassing 9,102 CTPA scans, all assessing the Aidoc or CINA-PE FDA-approved algorit…2025-10-01
Exact claim. Meta-analysis of six retrospective real-world studies encompassing 9,102 CTPA scans, all assessing the Aidoc or CINA-PE FDA-approved algorithms for acute pulmonary embolism detection, found pooled sensitivity of 93% (95% CI 88%-95%) and specificity of 98% (95% CI 93%-100%) (Cureus).
- Source
- pmc.ncbi.nlm.nih.gov
- Type
- peer reviewed study
- Published
- 2025-10-01
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Peer-reviewed. Check population, setting, and applicability to your workflow before generalizing.
Open pmc.ncbi.nlm.nih.govVerified provider experience is not yet publishable. Fewer than five independent provider organizations have contributed eligible reviews. Reviewer mode is off. Experience never changes documentary scoring, freshness, or rank.
Buyer lenses — evidence-backed bands (not a 0–100 rank)
Deployment, integration, data handling
- Integration maturity
- live — Listed on an EHR marketplace/partner program — live distribution.
- EHR path
- PACS/RIS via DICOM, Epic follow-up management modules
- FHIR / API
- UNKNOWN
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- SSO
- Supported
- PHI / BAA
- Imaging data under BAA; on-prem options · BAA available
- Security attestations
- SOC 2 Type II, HIPAA, ISO 13485 (quality system)
- FDA status
- CLEARED
- Pricing
- Not publicly listed
Technical provenance
snap_8a8a4c9bb810aee3 · 2026-08-27T04:05Z · build 6a9fe1b
Forecast calibration is not in the public snapshot — shown as UNKNOWN rather than read from SQLite.
Known limitations
- Deployment traction is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- Economic value evidence is UNKNOWN.
Why unknown
Why. No independently verifiable ROI claim (peer-reviewed, audited case, or independent benchmark) is on file.
What would close it. An audited implementation report or peer-reviewed study with payback/throughput numbers.