FDA product code · Radiology · Class 2
MYN: Analyzer, Medical Image
MYN is FDA's product code for "Analyzer, Medical Image": a Class 2 device classified under 21 CFR 892.2070, reviewed by the Radiology panel.
510(k) review time for MYN
Across 40 510(k) clearances under MYN decided from 2018-01-01 to 2026-10-06, the median was 215 days from FDA receipt to decision. Half took between 138 and 268 days, and 80% were decided within 270 days. These are past clearances, not a forecast for a new submission.
| Fastest | 103 |
|---|---|
| 25th percentile | 138 |
| Median | 215 |
| 75th percentile | 268 |
| 80th percentile | 270 |
| 90th percentile | 308 |
| Slowest | 447 |
| Year | Median days | n |
|---|---|---|
| 2022 | 273 | 5 |
| 2023 | 229 | 10 |
| 2025 | 210 | 14 |
| 2026 (to 10-06, partial) | 128 | 7 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MYN in the public FDA record
| 510(k) clearances, all years | 39 |
|---|
Counts of records, not of devices or events. Adverse event reports for MYN are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MYN
1 FDA recognized consensus standard cite MYN, among them IEEE Std 3333.2.1-2015. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-292 IEEE Std 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.