O-arm O2 Imaging System— 510(k) K240465
Substantially EquivalentMedtronic Navigation, Inc.
FDA 510(k) clearance K240465 for O-arm O2 Imaging System, Substantially Equivalent on 2024-06-21. Applicant: Medtronic Navigation, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Navigation, Inc.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boxborough, MA, US
Recent devices under product code OWB
view allMore clearances from Medtronic Navigation, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K240465
K-number listed on FDA's recall record- Z-2451-2026 — Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
- Z-2101-2025 — O-arm O2 Imaging System. Mobile X-Ray System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K240465.
Data sourced from openFDA. This site is unofficial and independent of the FDA.