QWO — Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Class II
FDA product code QWO covers "Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.", a Class II medical device regulated under 21 CFR 892.2085. Submissions are reviewed by the Radiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QWO
- Device Class
- Class II
- Regulation Number
- 892.2085
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.