510(k) DEN220040
- Device
- Fibresolve
- Applicant
- Imvaria, Inc.
- 510(k) number
- DEN220040
- Product code
- QWO
- Decision
- Unknown (DENG)
- Decision date
- 2024-01-12
- Date received
- 2022-06-29
- Regulation
- 892.2085
- Classification name
- Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Joshua Reicher
- Address
- 1748 Shattuck Ave. Pmb 137 Berkley CA US 94709 94709
FDA Registration Numbers#
- 3033729853
- 3017426576
Source Documents#
510(k) summary PDF not indicated by FDA