FDA product code QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture
QBS is the FDA product code for radiological computer assisted detection/diagnosis software for fracture. It is a Class II device, regulated under 21 CFR 892.2090 and reviewed by the Radiology panel. FDA has cleared 10 510(k) submissions under QBS, 9 in the last five years, from 7 different applicants. The average 510(k) review took 173 days (median 181); 154 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.
Classification
| Field | Value |
|---|---|
| Device name | Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| Device class | Class II |
| Regulation | 21 CFR 892.2090 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 234 |
| 2022 | 2 | 174 |
| 2023 | 2 | 204 |
| 2024 | 2 | 174 |
| 2025 | 1 | 177 |
| 2026 | 2 | 110 |
Compare with all 510(k) review times · Search every QBS clearance
Top QBS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| AZmed | 2 | 2026-08-28 |
| Azmed Sas | 2 | 2024-07-17 |
| Gleamer | 2 | 2023-03-02 |
| Milvue | 1 | 2025-01-17 |
| Icometrix NV | 1 | 2024-11-07 |
2 more applicants have QBS clearances. See the full list in Caduvo.
Most recent QBS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261378 | AZmed | Rayvolve AZchest | 2026-08-28 | 123 |
| K260378 | AZmed | Rayvolve | 2026-05-12 | 96 |
| K242171 | Milvue | TechCare Trauma | 2025-01-17 | 177 |
| K240712 | Icometrix NV | icobrain aria | 2024-11-07 | 237 |
| K240845 | Azmed Sas | Rayvolve | 2024-07-17 | 112 |
Recalls for QBS devices
openFDA lists no recalls for product code QBS.
Frequently asked questions
What is FDA product code QBS?
QBS is the FDA product code for radiological computer assisted detection/diagnosis software for fracture. It is a Class II device, regulated under 21 CFR 892.2090 and reviewed by the Radiology panel.
What device class is QBS?
Class II, regulation 21 CFR 892.2090. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBS?
Across 10 cleared submissions the average was 173 days from receipt to decision (median 181).
Which companies have the most QBS clearances?
AZmed (2); Azmed Sas (2); Gleamer (2); Milvue (1); Icometrix NV (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBS
- Run a recall and safety report across every QBS manufacturer
- Watch product code QBS 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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