K252041
- 510(k) number
- K252041
- Device name
- Fibresolve (with PCCP)
- Applicant
- Imvaria, Inc. CA · US
- Product code
- QWO — Radiology Software For Referral Of Findings Related
- Decision date
- 2025-11-07
- Date received
- 2025-06-30
- 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: K252041.pdf
Official FDA record: K252041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.