# K071717: GE Oec Altitude

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corp.
- Decided: Jul 5, 2007 after 13 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
This device is intended to be used for generating fluoroscopic images of human anatomy for the diagnostic, surgical and interventional angiography and cardiology procedures of circulatory vascular system. This device is operated and used by the physicians, X-ray technologist and radiologists. This device can be used in conjunction with a mobile or fixed surgical table.

Source page: https://510kreport.com/device/K071717
Methodology: https://510kreport.com/methodology