FDA product code MYN: Analyzer, Medical Image
MYN is the FDA product code for analyzer, medical image. It is a Class II device, regulated under 21 CFR 892.2070 and reviewed by the Radiology panel. FDA has cleared 40 510(k) submissions under MYN, 38 in the last five years, from 21 different applicants. The average 510(k) review took 218 days (median 215); 189 days on average over the last three years. 11 PMA applications cite this product code. FDA has posted 3 recalls for MYN devices.
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
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Medical Image |
| Device class | Class II |
| Regulation | 21 CFR 892.2070 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for MYN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 292 |
| 2022 | 5 | 281 |
| 2023 | 10 | 216 |
| 2024 | 2 | 172 |
| 2025 | 14 | 206 |
| 2026 | 7 | 189 |
Compare with all 510(k) review times · Search every MYN clearance
Top MYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Overjet, Inc. | 6 | 2026-08-06 |
| Pearl, Inc. | 6 | 2025-11-14 |
| Imagen Technologies, Inc. | 4 | 2023-10-03 |
| Velmeni, Inc. | 3 | 2026-05-11 |
| Videahealth, Inc. | 3 | 2025-09-19 |
16 more applicants have MYN clearances. See the full list in Caduvo.
Most recent MYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252486 | Gleamer | ChestView US (1.1) | 2026-09-09 | 398 |
| K261059 | Overjet, Inc. | Overjet Multi-Image Caries and Charting Assist | 2026-08-06 | 128 |
| K260851 | Better Diagnostics AI Corp. | Better Diagnostics Dental Assist (BDDA) Version 1.0 | 2026-07-15 | 121 |
| K252953 | Velmeni, Inc. | Velmeni for Dentists (V4D) Endo-Perio | 2026-05-11 | 237 |
| K251934 | Qure.Ai Technologies | qXR-Detect | 2026-01-16 | 206 |
Recalls for MYN devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-06.
Frequently asked questions
What is FDA product code MYN?
MYN is the FDA product code for analyzer, medical image. It is a Class II device, regulated under 21 CFR 892.2070 and reviewed by the Radiology panel.
What device class is MYN?
Class II, regulation 21 CFR 892.2070. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYN?
Across 40 cleared submissions the average was 218 days from receipt to decision (median 215).
Which companies have the most MYN clearances?
Overjet, Inc. (6); Pearl, Inc. (6); Imagen Technologies, Inc. (4); Velmeni, Inc. (3); Videahealth, Inc. (3).
Have MYN devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2015-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MYN
- Run a recall and safety report across every MYN manufacturer
- Watch product code MYN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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