# K123603: Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Decided: May 17, 2013 after 177 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K021049 (2002). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111551: Oec (R) 9800, Oec (R) 9800 Plus, Ge Oec Medical Systems, Inc. (2011) Summary page 1.

## Most influential descendants
- K172700: OEC One (2017), 3 descendants of its own
- K182626: OEC One (2018), 2 descendants of its own
- K240828: OEC One ASD (2024), 1 descendant of its own
- K253269: OEC One CFD (2025), 0 descendants of its own

## Recalls of this device
- Sep 23, 2016 · Class II · Z-0071-2017: GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the 
- Sep 15, 2014 · Class II · Z-0840-2015: mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as 
- Sep 15, 2014 · Class II · Z-0841-2015: mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as 
- May 22, 2014 · Class II · Z-1638-2015: Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
- Sep 18, 2013 · Class II · Z-0066-2014: GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.

## Indications for use
The OEC® Brivo® Mobile C-Arm X-Ray Products are designed to provide digital spot-film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localization/s or needle positions for aspirations, injections or biopsy. The OEC® Brivo® is not indicated for interventional use.

Source page: https://510kreport.com/device/K123603
Methodology: https://510kreport.com/methodology