FDA product code · Radiology · Class 2
QFM: Radiological Computer-Assisted Prioritization Software For Lesions
QFM is FDA's product code for "Radiological Computer-Assisted Prioritization Software For Lesions": a Class 2 device classified under 21 CFR 892.2080, reviewed by the Radiology panel.
510(k) review time for QFM
Across 41 510(k) clearances under QFM decided from 2018-01-01 to 2026-10-06, the median was 144 days from FDA receipt to decision. Half took between 100 and 225 days, and 80% were decided within 239 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 100 |
| Median | 144 |
| 75th percentile | 225 |
| 80th percentile | 239 |
| 90th percentile | 262 |
| Slowest | 416 |
| Year | Median days | n |
|---|---|---|
| 2021 | 187 | 5 |
| 2022 | 121 | 9 |
| 2023 | 206 | 8 |
| 2024 | 192 | 6 |
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.
QFM in the public FDA record
| 510(k) clearances, all years | 41 |
|---|
Counts of records, not of devices or events. Adverse event reports for QFM 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 QFM
No FDA recognized consensus standard cites QFM 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.