FDA product code QKB: Radiological Image Processing Software For Radiation Therapy
QKB is the FDA product code for radiological image processing software for radiation therapy. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 49 510(k) submissions under QKB, 35 in the last five years, from 29 different applicants. The average 510(k) review took 154 days (median 145); 164 days on average over the last three years.
Definition
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
Classification
| Field | Value |
|---|---|
| Device name | Radiological Image Processing Software For Radiation Therapy |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QKB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 26 |
| 2020 | 4 | 256 |
| 2021 | 9 | 123 |
| 2022 | 7 | 151 |
| 2023 | 7 | 123 |
| 2024 | 6 | 168 |
| 2025 | 6 | 156 |
| 2026 | 9 | 167 |
Compare with all 510(k) review times · Search every QKB clearance
Top QKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mim Software, Inc. | 7 | 2026-03-27 |
| Radformation, Inc. | 6 | 2026-08-14 |
| Ever Fortune.Ai, Co., Ltd. | 3 | 2026-01-28 |
| Manteia Technologies Co., Ltd. | 3 | 2026-01-23 |
| Vysioneer, Inc. | 3 | 2021-12-16 |
24 more applicants have QKB clearances. See the full list in Caduvo.
Most recent QKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262452 | Radformation, Inc. | AutoContour (RADAC V6) | 2026-08-14 | 28 |
| K261306 | Varian Medical Systems | AI Contouring (VA10A) | 2026-07-10 | 81 |
| K260528 | Oncosoft. Inc., | OncoStudio | 2026-07-02 | 135 |
| K252190 | Aitewan Biomedical Technology, Inc. | DeepBT Detector-Plus | 2026-04-10 | 270 |
| K252548 | Siemens Healthcare GmbH | AI-Rad Companion Organs RT | 2026-04-10 | 240 |
Recalls for QKB devices
openFDA lists no recalls for product code QKB.
Frequently asked questions
What is FDA product code QKB?
QKB is the FDA product code for radiological image processing software for radiation therapy. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is QKB?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code QKB?
Across 49 cleared submissions the average was 154 days from receipt to decision (median 145).
Which companies have the most QKB clearances?
Mim Software, Inc. (7); Radformation, Inc. (6); Ever Fortune.Ai, Co., Ltd. (3); Manteia Technologies Co., Ltd. (3); Vysioneer, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QKB
- Run a recall and safety report across every QKB manufacturer
- Watch product code QKB 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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