FDA product code QWO: Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
QWO is the FDA product code for radiology software for referral of findings related to fibrotic lung disease.. It is a Class II device, regulated under 21 CFR 892.2085 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under QWO, 3 in the last five years, from 2 different applicants. The average 510(k) review took 149 days (median 130); 142 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
Classification
| Field | Value |
|---|---|
| Device name | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. |
| Device class | Class II |
| Regulation | 21 CFR 892.2085 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QWO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 121 |
| 2025 | 2 | 163 |
Compare with all 510(k) review times · Search every QWO clearance
Top QWO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imvaria, Inc. | 2 | 2025-11-07 |
| Imbio, Inc. | 1 | 2024-12-19 |
Most recent QWO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252041 | Imvaria, Inc. | Fibresolve (with PCCP) | 2025-11-07 | 130 |
| K241891 | Imvaria, Inc. | ScreenDx | 2025-01-10 | 196 |
| K242467 | Imbio, Inc. | IQ-UIP | 2024-12-19 | 121 |
Recalls for QWO devices
openFDA lists no recalls for product code QWO.
Frequently asked questions
What is FDA product code QWO?
QWO is the FDA product code for radiology software for referral of findings related to fibrotic lung disease.. It is a Class II device, regulated under 21 CFR 892.2085 and reviewed by the Radiology panel.
What device class is QWO?
Class II, regulation 21 CFR 892.2085. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWO?
Across 3 cleared submissions the average was 149 days from receipt to decision (median 130).
Which companies have the most QWO clearances?
Imvaria, Inc. (2); Imbio, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QWO
- Run a recall and safety report across every QWO manufacturer
- Watch product code QWO 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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