# K133695: TITAN 11

- Pathway: 510(k) (Traditional)
- Applicant: Gemss Medical Systems Co., Ltd.
- Decided: Aug 7, 2014 after 247 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K051258 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051258: Kodak Directview DR 7500 System, Model 8791345, Eastman Kodak Company (2005) Summary page 7.

## Indications for use
TITAN 11 is a diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. This device is not intended for mammography.

Source page: https://510kreport.com/device/K133695
Methodology: https://510kreport.com/methodology