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., a class II device type, regulated under 21 CFR 892.2085. FDA's definition for this code reads: "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 of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QWO
- Device name
- Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
- FDA 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.
- Regulation
- 21 CFR 892.2085
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code QWO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 2 |
| 2025 | 2 |
Applicants with the most clearances
Product code QWO| Applicant | Clearances |
|---|---|
| Imvaria | 3 |
| Imbio, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.