# K111304: Optima XR120

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 19, 2011 after 71 days
- Product code: IXL (Device, Spot-Film)
- Device class: 2
- Regulation: 21 CFR 892.1670
- 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 K052897 (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)
- K052897: GE Definium Amx 700, Model Amx 700, General Electric Medical Systems (2005) Summary page 1.

## Indications for use
The Optima XR120 is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating images on film or digitally. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K111304
Methodology: https://510kreport.com/methodology