O-ARM IMAGING SYSTEM
FDA 510(k) clearance K050996 · decided 2005-05-05
Clearance details
- K-number
- K050996
- Device name
- O-ARM IMAGING SYSTEM
- Applicant
- Breakaway Imaging, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-04-20
- Decision date
- 2005-05-05
- Days to decision
- 15 days
- Clearance type
- Abbreviated
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Littleton, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medica recall (Z-1998-2010) | Medtronic Navigation, Inc. | 2010-07-13 |
| Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 recall (Z-0624-2009) | Medtronic Navigation, Inc | 2009-02-04 |
| BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of recall (Z-2034-2008) | Medtronic Navigation, Inc. | 2008-09-26 |
| Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation recall (Z-0294-2008) | Medtronic Navigation, Inc | 2007-11-27 |