FDA product code QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
QDQ is the FDA product code for radiological computer assisted detection/diagnosis software for lesions suspicious for cancer. It is a Class II device, regulated under 21 CFR 892.2090 and reviewed by the Radiology panel. FDA has cleared 40 510(k) submissions under QDQ, 28 in the last five years, from 16 different applicants. The average 510(k) review took 158 days (median 153); 167 days on average over the last three years.
Definition
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion 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 Lesions Suspicious For Cancer |
| 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 QDQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 122 |
| 2019 | 2 | 90 |
| 2020 | 3 | 164 |
| 2021 | 5 | 167 |
| 2022 | 4 | 164 |
| 2023 | 2 | 149 |
| 2024 | 7 | 141 |
| 2025 | 5 | 200 |
| 2026 | 10 | 161 |
Compare with all 510(k) review times · Search every QDQ clearance
Top QDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Screenpoint Medical B.V. | 7 | 2026-08-14 |
| Therapixel | 5 | 2026-06-26 |
| DeepHealth, Inc. | 5 | 2026-06-15 |
| Lunit, Inc. | 5 | 2026-04-23 |
| Hologic, Inc. | 4 | 2025-07-31 |
11 more applicants have QDQ clearances. See the full list in Caduvo.
Most recent QDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261517 | Qure.Ai Technologies Pvt. , Ltd. | qCT Lung (v1.0) | 2026-09-14 | 130 |
| K260898 | Screenpoint Medical B.V. | Transpara (2.1.0) | 2026-08-14 | 149 |
| K260086 | BeamWorks, Inc. | CadAI-B Dx | 2026-08-12 | 212 |
| K260303 | See-Mode Technologies Pty, Ltd. | See-Mode Augmented Reporting Tool, Breast (SMART-B) | 2026-07-28 | 179 |
| K260714 | Therapixel | MammoScreen® (5) | 2026-06-26 | 113 |
Recalls for QDQ devices
openFDA lists no recalls for product code QDQ.
Frequently asked questions
What is FDA product code QDQ?
QDQ is the FDA product code for radiological computer assisted detection/diagnosis software for lesions suspicious for cancer. It is a Class II device, regulated under 21 CFR 892.2090 and reviewed by the Radiology panel.
What device class is QDQ?
Class II, regulation 21 CFR 892.2090. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDQ?
Across 40 cleared submissions the average was 158 days from receipt to decision (median 153).
Which companies have the most QDQ clearances?
Screenpoint Medical B.V. (7); Therapixel (5); DeepHealth, Inc. (5); Lunit, Inc. (5); Hologic, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code QDQ
- Run a recall and safety report across every QDQ manufacturer
- Watch product code QDQ 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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