O-arm O2 Imaging System
FDA 510(k) K240465 · Medtronic Navigation, Inc.
510(k) numberK240465
Submission
- Device name
- O-arm O2 Imaging System
- Applicant
- Medtronic Navigation, Inc.
Boxborough, MA, US - Received
- February 16, 2024
- Decision date
- June 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was O-arm O2 Imaging System cleared by the FDA?
O-arm O2 Imaging System (K240465) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 126 days after the submission was received.
What is the product code of K240465?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.