FDA product code · Radiology · Class 2
MWP: Cabinet, X-Ray System
MWP is FDA's product code for "Cabinet, X-Ray System": a Class 2 device classified under 21 CFR 892.1680, reviewed by the Radiology panel.
510(k) review time for MWP
Across 14 510(k) clearances under MWP decided from 2018-01-01 to 2026-10-06, the median was 100 days from FDA receipt to decision. Half took between 73 and 154 days, and 80% were decided within 162 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 73 |
| Median | 100 |
| 75th percentile | 154 |
| 80th percentile | 162 |
| 90th percentile | 175 |
| Slowest | 203 |
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.
FDA-recognized standards that cite MWP
No FDA recognized consensus standard cites MWP by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.