# K043076: GE Oec Fluorostar

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems, Inc.
- Decided: Dec 22, 2004 after 44 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091918: Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro (2009), 4 descendants of its own
- K181943: OSCAR (OSCAR Prime, OSCAR Classic) (2018), 1 descendant of its own
- K170946: Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant (2017), 1 descendant of its own
- K252229: Belliger Ace (2026), 0 descendants of its own
- K251893: Skan C Pulsar (2025), 0 descendants of its own

## Recalls of this device
- Feb 19, 2009 · Not classified · Z-1155-2009: The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.

## Indications for use
The OEC Fluorostar is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.

Source page: https://510kreport.com/device/K043076
Methodology: https://510kreport.com/methodology