4 devices · 3 companies · 2024 to 2025
Product code QWO: Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
4 devices under product code QWO, 2024 to 2025, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.. 21 CFR 892.2085, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| FibresolveK252041 · 510(k) | Imvaria, Inc. | Radiology | database entry | |
| ScreenDxK241891 · 510(k) | Imvaria, Inc | Radiology | database entry | |
| IQ-UIPK242467 · 510(k) | Imbio, Inc. | Radiology | database entry | |
| FibresolveDEN220040 · De Novo | Imvaria, Inc | Radiology | database entry |
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