DEN220040
- 510(k) number
- DEN220040
- Device name
- Fibresolve
- Applicant
- Imvaria, Inc. CA · US
- Product code
- QWO — Radiology Software For Referral Of Findings Related
- Decision date
- 2024-01-12
- Date received
- 2022-06-29
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Radiology
Official FDA record: DEN220040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.