# K992506: Mini 6800 Digital Mobile C-Arm

- Pathway: 510(k) (Abbreviated)
- Applicant: Ge Dec Medical Systems
- Decided: Aug 19, 1999 after 23 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MINI 6600 Digital Mobile C-arm: named in the summary without a submission number
- (no number) FluoroScan Premier: named in the summary without a submission number
- (no number) ORCA Orthopedic C-arm: named in the summary without a submission number

## Most influential descendants
- K160131: OEC Elite MiniView (2016), 1 descendant of its own
- K171800: OEC Elite MiniView (2017), 0 descendants of its own

## Recalls of this device
- Dec 19, 2016 · Class II · Z-0974-2017: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord fail
- Oct 3, 2014 · Class II · Z-0193-2015: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
- Jun 12, 2007 · Not classified · Z-0851-2007: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- May 24, 2007 · Not classified · Z-0928-2007: X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures
- Mar 27, 2007 · Class II · Z-2126-2012: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the h
- Nov 20, 2006 · Class I · Z-2040-2012: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 6800 Miniview was recalled in Nov
- Mar 28, 2006 · Not classified · Z-0704-06: Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.

## Indications for use
The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.

Source page: https://510kreport.com/device/K992506
Methodology: https://510kreport.com/methodology