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Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
FDA product code POK · Class 2 · Radiology
48
Registered devices
1
Adverse events
0
Recalls
23
510(k) clearances
Devices with this code
Unfold AI — Avenda Health, Inc.Unfold AI — Avenda Health, Inc.iQuest — Avenda Health, Inc.RevealAI-Lung — Precision Medical Ventures Inc.Unfold AI — Avenda Health, Inc.Rapid — Ischemaview, Inc.Rapid — Ischemaview, Inc.Unfold AI — Avenda Health, Inc.Rapid — Ischemaview, Inc.Rapid — Ischemaview, Inc.Rapid — Ischemaview, Inc.e-ASPECTS — BRAINOMIX LIMITEDB-Right Screen Fetal Heart — BRIGHTHEARTB-Right Screen Fetal Heart — BRIGHTHEARTBrainomix e-ASPECTS — BRAINOMIX LIMITEDEchoSolv AS — ECHOIQ LIMITEDUnfold AI — Avenda Health, Inc.AISAP Cardio V1.0 — AISAP LTDKoios DS — KOIOS MEDICAL, INC.Unfold AI — Avenda Health, Inc.Rapid — Ischemaview, Inc.Unfold AI — Avenda Health, Inc.Rapid — Ischemaview, Inc.Rapid — Ischemaview, Inc.
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