K251934
- 510(k) number
- K251934
- Device name
- qXR-Detect
- Applicant
- Qure.Ai Technologies IN
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2026-01-16
- Date received
- 2025-06-24
- 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: K251934.pdf
Official FDA record: K251934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.