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Analyzer, Medical Image
FDA product code MYN · Class 2 · Radiology
137
Registered devices
5
Adverse events
3
Recalls
40
510(k) clearances
Devices with this code
ChestView US — GLEAMERClearRead +Detect — Riverain Technologies, Inc.ClearRead +Detect — Riverain Technologies, Inc.DTX Studio™ Clinic — Nobel Biocare ABClearRead Detect Docker — Riverain Technologies, Inc.DTX Studio™ Clinic — Nobel Biocare ABPowerLook PRO Tomo Detection and SLD, GE — Icad, Inc.ClearRead Detect Docker — Riverain Technologies, Inc.DTX Studio™ Assist — Nobel Biocare ABQVCAD System — QVIEW MEDICALVidea Dental Assist — Videahealth, Inc.Powerlook PRO Hardware Upgrade, SLD — Icad, Inc.ClearRead Xray Detect — Riverain Technologies, Inc.ClearRead Xray Detect — Riverain Technologies, Inc.QVCAD System — QVIEW MEDICALClearRead +Detect — Riverain Technologies, Inc.QVCAD System Installation Kit — QVIEW MEDICALClearRead Xray | Detect — Riverain Technologies, Inc.Logicon Caries Detector — G. A IndustriesDTX Studio™ Clinic — Nobel Biocare ABDTX Studio™ Clinic — Nobel Biocare ABDTX Studio™ Clinic — Nobel Biocare ABOverjet Calculus Assist — Overjet, Inc.Powerlook PRO Hardware Upgrade, SLD — 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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