Fibresolve
FDA 510(k) clearance DEN220040 · decided 2024-01-12
Clearance details
- K-number
- DEN220040
- Device name
- Fibresolve
- Applicant
- Imvaria, Inc.
- Decision
- Unknown
- Date received
- 2022-06-29
- Decision date
- 2024-01-12
- Days to decision
- 562 days
- Clearance type
- Direct
- Product code
- QWO
- Device class
- 2
- Regulation number
- 892.2085
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Berkley, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fibresolve (with PCCP) (K252041) | Imvaria, Inc. | 2025-11-07 |
| ScreenDx (K241891) | Imvaria, Inc. | 2025-01-10 |
| IQ-UIP (K242467) | Imbio, Inc. | 2024-12-19 |
Recalls involving this device
No recalls on record reference this clearance.