FDA Product Code
FDA Product Code QWO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2085
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | 2025-11-07 | Traditional | PDF ↗ |
| K241891 | ScreenDx | Imvaria, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K242467 | IQ-UIP | Imbio, Inc. | 2024-12-19 | Traditional | PDF ↗ |
| DEN220040 | Fibresolve | Imvaria, Inc. | 2024-01-12 | Direct | — |
Product code QWO · Class II · Radiology. Data: openFDA.