K253296
- 510(k) number
- K253296
- Device name
- Digital C-ARM with 3D
- Applicant
- Allengers Medical Systems Limited IN
- Product code
- OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
- Decision date
- 2026-06-05
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K253296.pdf
Official FDA record: K253296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.