Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Regulation 892.2085
1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QWO
| Company | 510(k)s | Recalls |
|---|---|---|
| Imvaria, Inc. | 3 | 0 |
| Imbio, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2025 | K252041 | Fibresolve (with PCCP) Imvaria, Inc. | QWO |
| Jan 10, 2025 | K241891 | ScreenDx Imvaria, Inc. | QWO |
| Dec 19, 2024 | K242467 | IQ-UIP Imbio, Inc. | QWO |
| Jan 12, 2024 | DEN220040 | Fibresolve Imvaria, Inc. | QWO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.