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Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA product code QDQ · Class 2 · Radiology

24

Registered devices

0

Adverse events

0

Recalls

39

510(k) clearances

Devices with this code

Transpara — Screenpoint Medical B.V.MammoScreen — THERAPIXEL Lunit INSIGHT MMG — Lunit Inc.Transpara — Screenpoint Medical B.V.Saige-Dx — Deephealth, Inc.MammoScreen — THERAPIXEL See-Mode Technologies — SEE-MODE TECHNOLOGIES PTE. LTD.ProFound Detection — Icad, Inc.Bot Image, Inc. — Bot Image, Inc.QP-Prostate® CAD — QUIBIM SOCIEDAD LIMITADA.Transpara — Screenpoint Medical B.V.Transpara — Screenpoint Medical B.V.Transpara — Screenpoint Medical B.V.Transpara — Screenpoint Medical B.V.QP-Prostate® CAD — QUIBIM SOCIEDAD LIMITADA.QP-Prostate® CAD — QUIBIM SOCIEDAD LIMITADA.ProFound AI — Icad, Inc.Lunit INSIGHT DBT — Lunit Inc.Bot Image, Inc. — Bot Image, Inc.Lunit INSIGHT DBT — Lunit Inc.PowerLook Tomo Detection (ProFound AI) — Icad, Inc.ProFound AI V3.0 — Icad, Inc.Bot Image, Inc. — Bot Image, Inc.Lunit INSIGHT DBT — Lunit Inc.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.