K240465
- 510(k) number
- K240465
- Device name
- O-arm O2 Imaging System
- Applicant
- Medtronic Navigation, Inc. MA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-06-21
- Date received
- 2024-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240465.pdf
Official FDA record: K240465
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.