K241891
- 510(k) number
- K241891
- Device name
- ScreenDx
- Applicant
- Imvaria, Inc. CA · US
- Product code
- QWO — Radiology Software For Referral Of Findings Related
- Decision date
- 2025-01-10
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241891.pdf
Official FDA record: K241891
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.