OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
FDA 510(k) clearance K123603 · decided 2013-05-17
Clearance details
- K-number
- K123603
- Device name
- OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
- Applicant
- Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-21
- Decision date
- 2013-05-17
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC recall (Z-0071-2017) | GE OEC Medical Systems, Inc | 2016-10-11 |
| GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) recall (Z-1638-2015) | GE OEC Medical Systems, Inc | 2015-06-08 |
| GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications a recall (Z-0840-2015) | GE OEC Medical Systems, Inc | 2015-01-13 |
| GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications an recall (Z-0841-2015) | GE OEC Medical Systems, Inc | 2015-01-13 |
| GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Bri recall (Z-0066-2014) | GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD | 2013-10-24 |