O-Arm O2 Imaging System
FDA 510(k) clearance K151000 · decided 2015-08-06
Clearance details
- K-number
- K151000
- Device name
- O-Arm O2 Imaging System
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-15
- Decision date
- 2015-08-06
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Littleton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging fo recall (Z-2026-2024) | Medtronic Navigation, Inc.-Littleton | 2024-06-06 |
| The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D i recall (Z-2449-2023) | Medtronic Navigation, Inc.-Littleton | 2023-08-24 |
| O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 recall (Z-0767-2020) | Medtronic Navigation, Inc.-Littleton | 2019-12-31 |
| Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 recall (Z-0070-2017) | Medtronic Navigation, Inc.-Littleton | 2016-10-11 |
| Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System recall (Z-1088-2016) | Medtronic Navigation, Inc. | 2016-03-08 |
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