Product code MYN
- Device name
- Analyzer, Medical Image
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2070
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- 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
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P980025S004 | Logicon Caries Detection Software | Carestream Dental, LLC | 2019-09-05 |
| P150043S001 | QVCAD System (Version 3.3) | Qview Medical, Inc. | 2017-12-14 |
| P160009 | PowerLook® Tomo Detection Software | Icad, Inc. | 2017-03-24 |
| P100005S007 | M-VU ALGORITHM ENGINE | Icad, Inc. | 2017-01-11 |
| P150043 | QVCAD SYSTEM | Qview Medical, Inc. | 2016-11-09 |
| P970058S027 | IMAGE CHECKER, IMAGE CHECKER LICENSE | Hologic, Inc. | 2016-04-26 |
| P980025S003 | LOGICON CARIES DETECTOR | Carestream Dental, LLC | 2015-12-10 |
| P120004S001 | PARASCRIPT (R) ACCUDETECT (R) | Parascript, LLC | 2015-10-16 |
| P100005S005 | M-VU ALGORITHM ENGINE | Icad, Inc. | 2015-03-02 |
| P980025S002 | LOGICON CARIES DETECTOR | Carestream Dental, LLC | 2014-07-22 |
| P100005S004 | M-VU ALGORITHM ENGINE | Icad, Inc. | 2014-06-06 |
| P970058S026 | IMAGE CHECKER CAD | Hologic, Inc. | 2014-02-10 |
| P100005S003 | M-VU ALGORITHM ENGINE | Icad, Inc. | 2013-12-02 |
| P120004 | PARASCRIPT ACCUDETECT 6.1.0 | Parascript, LLC | 2013-08-22 |
| P100005S002 | M-VU ALGORITHM ENGINE | Icad, Inc. | 2013-06-19 |
| P010038S017 | SECONDLOOK DIGITAL | Icad, Inc. | 2013-06-19 |
| P010038S016 | SECONDLOOK DIGITAL V7.2 CAD | Icad, Inc. | 2012-11-09 |
| P100005S001 | M-VU ALGOIRITHM ENGINE | Icad, Inc. | 2012-10-01 |
| P970058S025 | IMAGECHECKER CAD | Hologic, Inc. | 2012-09-21 |
| P000041S011 | CLEAREAD DETECT | Riverain Medical Group | 2012-02-27 |
| P100007 | BREAST COMPANION SOFTWARE SYSTEM | Almen Laboratories, Inc. | 2012-02-10 |
| P100005 | M-VU ALGORITHM ENGINE | Icad, Inc. | 2012-01-23 |
| P000041S010 | CLEARREAD DETECT | Riverain Medical Group | 2011-11-08 |
| P010038S013 | SECONDLOOK (SL) CAD | Icad, Inc. | 2010-12-07 |
| P000041S009 | ONGUARD | Riverain Medical Group | 2010-06-10 |
| P010038S015 | SECONDLOOK (SL) CAD | Icad, Inc. | 2008-10-09 |
| P010038S012 | SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM | Icad, Inc. | 2008-04-04 |
| P000041S006 | ONGUARD | Riverain Medical Group | 2007-08-30 |
| P010038S014 | SECONDLOOK | Icad, Inc. | 2007-07-27 |
| P030007S003 | KODAK MAMMOGRAPHY CAD ENGINE | Carestream Health, Inc. | 2007-03-23 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 |
| K251934 | qXR-Detect | Qure.Ai Technologies | 2026-01-16 |
| K252934 | Diagnocat | DGNCT, LLC | 2026-01-15 |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 2026-01-07 |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025-11-17 |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025-11-14 |
| K250264 | SugarBug (1.x) | Bench7, Inc. | 2025-11-07 |
| K251002 | Videa Dental AI | Videahealth, Inc. | 2025-09-19 |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 |
| K242437 | Smile Dx® | Cube Click, Inc. | 2025-05-14 |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 |
| K243239 | Lung AI (LAI001) | Exo, Inc. | 2025-04-24 |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025-04-11 |
| K243831 | Rayvolve LN | AZmed | 2025-03-26 |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | 2025-03-11 |
| K241620 | ChestView US | Gleamer Sas | 2025-02-27 |
| K242522 | Second Opinion CC | Pearl, Inc. | 2025-01-16 |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024-08-30 |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024-03-04 |
| K231805 | qXR-LN | Qure.Ai Technologies | 2023-12-22 |
| K232384 | Videa Dental Assist | Videahealth, Inc. | 2023-12-15 |
| K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023-10-06 |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 |
| K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023-10-03 |
| K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023-09-21 |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | 2023-09-13 |
| K223133 | VisiRad XR | Imidex, Inc. | 2023-08-03 |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023-03-28 |
| K222746 | Overjet Caries Assist | Overjet, Inc. | 2023-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04262352357935 | DS Core Detect | Zetta25 AG | 2026-06-03 |
| 00852491008047 | ChestSuite | Imagen Technologies, Inc. | 2026-04-15 |
| 00860015071101 | SugarBot | BENCH7 INC. | 2026-04-08 |
| 07332747236637 | DTX Studio™ Clinic | Nobel Biocare AB | 2026-03-27 |
| 07332747236620 | DTX Studio™ Clinic | Nobel Biocare AB | 2026-03-27 |
| 08801643467098 | NA | Samsung Electronics Co., Ltd. | 2026-03-17 |
| 00860010268063 | Diagnocat | DGNCT LLC | 2026-01-29 |
| 07332747221862 | DTX Studio™ Assist | Nobel Biocare AB | 2025-12-01 |
| 07332747221855 | DTX Studio™ Assist | Nobel Biocare AB | 2025-12-01 |
| 07332747225518 | DTX Studio™ Clinic | Nobel Biocare AB | 2025-10-06 |
| 07332747225501 | DTX Studio™ Clinic | Nobel Biocare AB | 2025-10-06 |
| 00198715016079 | Second Opinion | Pearl Inc. | 2025-07-31 |
| M722XD25114C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-06-17 |
| M722XC25114C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-06-17 |
| M722X25122C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-06-17 |
| 07332747221183 | DTX Studio™ Clinic | Nobel Biocare AB | 2025-04-24 |
| 07332747221190 | DTX Studio™ Clinic | Nobel Biocare AB | 2025-04-24 |
| 08908023670038 | DeepTek CXR Analyzer | DEEPTEK MEDICAL IMAGING PRIVATE LIMITED | 2025-04-24 |
| 03770020839092 | ChestView US | GLEAMER | 2025-04-02 |
| M722X25064C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-03-27 |
| 07332747219616 | DTX Studio™ Clinic | Nobel Biocare AB | 2025-01-26 |
| 07332747219623 | DTX Studio™ Clinic | Nobel Biocare AB | 2025-01-26 |
| 07332747215229 | DTX Studio™ Clinic | Nobel Biocare AB | 2024-04-17 |
| 07332747202830 | DTX Studio™ Clinic | Nobel Biocare AB | 2024-01-30 |
| 07332747202854 | DTX Studio™ Clinic | Nobel Biocare AB | 2024-01-30 |
| 07332747200577 | DTX Studio™ Clinic | Nobel Biocare AB | 2023-06-16 |
| 07332747200584 | DTX Studio™ Clinic | Nobel Biocare AB | 2023-06-16 |
| 07332747199789 | DTX Studio™ Clinic | Nobel Biocare AB | 2023-04-06 |
| 07332747199772 | DTX Studio™ Clinic | Nobel Biocare AB | 2023-04-06 |
| 00860009836808 | Videa Caries Assist | Videahealth, Inc. | 2023-01-23 |