# K052039: GE Oec Altitude

- Pathway: 510(k) (Abbreviated)
- Applicant: Ge Oec Medical Systems
- Decided: Aug 11, 2005 after 14 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943545 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943545: Ceiling Suspended C-Arm Support MH-100, Shimadzu Medical Systems (1995) Summary page 1.
- K955395: DAR-2400-15B/30B, Shimadzu Medical Systems (1995) Summary page 1.

## Indications for use
GE OEC Altitude is a Fluoroscopic Imaging System designed to provide fluoroscopic images of the patient during diagnostic, surgical and interventional angiography and cardiology procedures.

Source page: https://510kreport.com/device/K052039
Methodology: https://510kreport.com/methodology