510(k) K241891
- Device
- ScreenDx
- Applicant
- Imvaria, Inc.
- 510(k) number
- K241891
- Product code
- QWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-10
- Date received
- 2024-06-28
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Joshua Reicher
- Address
- 2930 Domingo Ave. #1496 Berkeley CA US 94705 94705
FDA Registration Numbers
- 3033729853
- 3017426576