510(k) K123603 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
| Applicant | Ge Healthcare Surgery GE Oec Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 17, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2016 | GE OEC Medical Systems, Inc OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance
Product Usage:
The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image g Terminated |
OXO | None listed |
| Jun 8, 2015 | GE OEC Medical Systems, Inc GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) Terminated |
OXO | None listed |
| Jan 13, 2015 | GE OEC Medical Systems, Inc GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product
Used for general surgical applications and musculoskeletal procedures to visualize. Terminated |
OXO | None listed |
| Jan 13, 2015 | GE OEC Medical Systems, Inc GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product
Used for general surgical applications and musculoskeletal procedures to visualize. Terminated |
OXO | None listed |
| Oct 24, 2013 | GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus.
The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guida Terminated |
OXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.