Analyzer, Medical Image
Radiology · 21 CFR 892.2070
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
Recent MDR events
5 adverse event reports on file
- SECOND OPINIONMar 13, 2025InjuryPearl Inc.MW5167620
- OVERJET CARIES ASSISTFeb 18, 2025MalfunctionOverjetMW5166306
- PEARL SECOND OPINIONApr 15, 2024MalfunctionPearl Inc.MW5153880
- POWERLOOK AMP WITH SECONDLOOK DIGITAL GEJan 11, 2018MalfunctionIcad, Incorporated1225671-2018-00001
- RAPIDSCREEN RS-2000D AND RS-DIGITALMay 18, 2006MalfunctionRiverain Medical3005156333-2006-00001
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- GA IndustriesTerminatedApr 27, 2015
Logicon Caries Detector
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 release.
Z-1537-2015 · View FDA record ↗ - Riverain Medical GroupTerminatedJun 27, 2006
RapidScreen RS-2000D, Medical Image Analyzer.
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 a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
Z-1173-06 · View FDA record ↗ - Riverain Medical GroupTerminatedJun 27, 2006
RapidScreen RS-Digital, Medical Image Analyzer.
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 a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
Z-1174-06 · View FDA record ↗
Registered firms
47 firms currently registered for this product code
Imagen Technologies, Inc.
New York, NY, US
Dgnct Llc
Miami, FL, US
Nobel Biocare Ab
GOTEBORG Vastra Gotaland, SE
Samsung Electronics Co., Ltd.
Seoul, KR
Nobel Biocare C/o Medicim Nv
Mechelen Antwerpen, BE
Hologic, Inc.
Newark, DE, US
Carestream Dental Technology Topco Limited
London London, City of, GB
Azmed Sas
Paris, FR
Pearl Inc.
West Hollywood, CA, US
Videahealth, Inc.
Boston, MA, US
Palodex Group Oy
Tuusula Uusimaa, FI
Carestream Dental Llc
Atlanta, GA, US
Riverain Technologies
MIAMISBURG, OH, US
Deeptek Medical Imaging Pvt. Ltd
Pune Maharashtra, IN
Qure.ai Technologies Private Limited
Mumbai Maharashtra, IN
Nobel Biocare Services Ag
Kloten Zurich, CH
Overjet
Boston, MA, US
510(k) clearances
39 clearances for this product code
- Overjet, Inc.Aug 6, 2026
K261059 · Overjet Multi-Image Caries and Charting Assist
- Better Diagnostics AI Corp.Jul 15, 2026
K260851 · Better Diagnostics Dental Assist (BDDA) Version 1.0
- Velmeni, Inc.May 11, 2026
K252953 · Velmeni for Dentists (V4D) Endo-Perio
- Qure.Ai TechnologiesJan 16, 2026
K251934 · qXR-Detect
- DGNCT, LLCJan 15, 2026
K252934 · Diagnocat
- Dentsply Sirona, Inc.Jan 7, 2026
K253009 · DS Core Detect
- Nobel Biocare C/O Medicim NVNov 17, 2025
K252086 · DTX Studio Assist
- Pearl, Inc.Nov 14, 2025
K250525 · Second Opinion® Panoramic
PMA approvals
11 premarket approvals for this product code
- Icad, Inc.Mar 24, 2017
P160009 · PowerLook® Tomo Detection Software
- Qview Medical, Inc.Nov 9, 2016
P150043 · QVCAD SYSTEM
- Parascript, LLCAug 22, 2013
P120004 · PARASCRIPT ACCUDETECT 6.1.0
- Almen Laboratories, Inc.Feb 10, 2012
P100007 · BREAST COMPANION SOFTWARE SYSTEM
- Icad, Inc.Jan 23, 2012
P100005 · M-VU ALGORITHM ENGINE
- Carestream Health, Inc.Nov 23, 2004
P030007 · KODAK MAMMOGRAPHY CAD ENGINE
- Icad, Inc.Jan 31, 2002
P010034 · SECOND LOOK (TM)
- Icad, Inc.Jan 15, 2002
P010038 · SECOND LOOK