O-ARM IMAGING SYSTEM
FDA 510(k) clearance K092564 · decided 2010-06-17
Clearance details
- K-number
- K092564
- Device name
- O-ARM IMAGING SYSTEM
- Applicant
- Medtronic Navigation, Inc. (Littleton)
- Decision
- Substantially Equivalent
- Date received
- 2009-08-20
- Decision date
- 2010-06-17
- Days to decision
- 301 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
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-0002 recall (Z-0973-2014) | Medtronic Navigation, Inc. | 2014-02-28 |
| Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, recall (Z-0926-2013) | Medtronic Navigation, Inc. | 2013-03-08 |
| Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-7 recall (Z-2244-2012) | Medtronic Navigation, Inc. | 2012-08-22 |
| Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027- recall (Z-1849-2012) | Medtronic Navigation, Inc. | 2012-06-21 |
| Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Ca recall (Z-0447-2011) | Medtronic Navigation, Inc. | 2010-11-23 |