Imaging & Diagnostic AI · Assurance Record

Lunit INSIGHT

Name: Lunit INSIGHT
Author: Lunit

Lunit · Screening + hospital · Cloud + on-prem

Decision summary

Suitable for: Imaging centers, hospital radiology, screening programs
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 2 evidence claims independently confirmed · confidence Low
Critical unknowns: No critical documentary gaps identified
Last independent review: not yet measured

Documentary evidence — view claim and provenance

independent reportLunit INSIGHT DBT (V1.2) FDA clearance listed March 2026 on the FDA AI-enabled device list.2026-03-26

Exact claim. Lunit INSIGHT DBT (V1.2) FDA clearance listed March 2026 on the FDA AI-enabled device list.

Source: fda.gov
Type: independent report
Published: 2026-03-26
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.gov

peer reviewed studyLunit INSIGHT MMG (Lancet Digital Health 2020): the AI algorithm was developed and validated on 170,230 mammography examinations from five i…2020-03-01

Exact claim. Lunit INSIGHT MMG (Lancet Digital Health 2020): the AI algorithm was developed and validated on 170,230 mammography examinations from five institutions; in a multicentre, observer-blinded reader study of 320 mammograms read by 14 radiologists, AI performance (AUROC 0.940) significantly exceeded radiologists without assistance (AUROC 0.810, p<0.0001), and AI assistance improved radiologists' performance to AUROC 0.881 (p<0.0001).

Source: doi.org
Type: peer reviewed study
Published: 2020-03-01
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 doi.org

Verified deployment experience

Verified 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)

Clinical · Thinner · missing deployment_traction, economic_value, market_durability

Operations · Thinner · missing deployment_traction, economic_value

Security & Privacy · Moderate · missing deployment_traction, market_durability

IT & Interop · Thinner · missing deployment_traction, market_durability

Finance & Procurement · Thinner · missing deployment_traction, economic_value, market_durability

Strategic · Thinner · missing deployment_traction, market_durability

Deployment, integration, data handling

Integration maturity: live — Listed on an EHR marketplace/partner program — live distribution.
EHR path: DICOM/PACS integration
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: UNKNOWN
Why unknown
Why. Single-sign-on support is not documented in vendor or marketplace materials on file.
What would close it. Vendor security documentation or marketplace listing mentioning SSO/SAML/OIDC.
PHI / BAA: Imaging under BAA for US deployments · BAA available
Security attestations: ISO 13485, CE MDR
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.
Market durability 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.

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