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Analyzer, Medical Image
FDA product code MYN · Class 2 · Radiology
136
Registered devices
5
Adverse events
3
Recalls
39
510(k) clearances
Devices with this code
Logicon Caries Detector — G. A IndustriesClearRead Detect Docker — Riverain Technologies, Inc.Logicon Caries Detector — G. A IndustriesAorta-CAD — Imagen Technologies, Inc.ClearRead +Detect — Riverain Technologies, Inc.ClearRead Xray | Detect — Riverain Technologies, Inc.Powerlook PRO with SLD, FRU — Icad, Inc.Logicon Caries Detector — CARESTREAM HEALTH, INC.QVCAD System Installation Kit — QVIEW MEDICALImageChecker CAD 10.0 — Hologic, Inc.Chest-CAD — Imagen Technologies, Inc.PowerLook AMP SLD GE OUS — Icad, Inc.Powerlook PRO Hardware Upgrade, SLD — Icad, Inc.Videa Dental Assist — Videahealth, Inc.DTX Studio™ Clinic — Nobel Biocare ABPowerLook AMP SLD GE OUS Direct — Icad, Inc.PowerLook AMP SLD FRU GE — Icad, Inc.QVCAD System — QVIEW MEDICALDTX Studio™ Clinic — Nobel Biocare ABDeepTek CXR Analyzer — DEEPTEK MEDICAL IMAGING PRIVATE LIMITEDDTX Studio™ Clinic — Nobel Biocare ABClearRead +Detect — Riverain Technologies, Inc.ClearRead Detect Console — Riverain Technologies, Inc.PowerLook PRO Tomo Detection FRU — Icad, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-06 | GA Industries | GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product |
| 2006-05-04 | Riverain Medical Group | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and |
| 2006-05-04 | Riverain Medical Group | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and |
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