FDA product code · Radiology · Class 2
QKB: Radiological Image Processing Software For Radiation Therapy
QKB is FDA's product code for "Radiological Image Processing Software For Radiation Therapy": a Class 2 device classified under 21 CFR 892.2050, reviewed by the Radiology panel.
510(k) review time for QKB
Across 49 510(k) clearances under QKB decided from 2018-01-01 to 2026-10-06, the median was 145 days from FDA receipt to decision. Half took between 90 and 230 days, and 80% were decided within 233 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 90 |
| Median | 145 |
| 75th percentile | 230 |
| 80th percentile | 233 |
| 90th percentile | 268 |
| Slowest | 319 |
| Year | Median days | n |
|---|---|---|
| 2021 | 120 | 9 |
| 2022 | 162 | 7 |
| 2023 | 111 | 7 |
| 2024 | 173 | 6 |
| 2025 | 170 | 6 |
| 2026 (to 10-06, partial) | 179 | 9 |
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.
QKB in the public FDA record
| 510(k) clearances, all years | 49 |
|---|
Counts of records, not of devices or events. Adverse event reports for QKB 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 QKB
No FDA recognized consensus standard cites QKB 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.