# K142383: Optima XR200amx, Optima XR220amx

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 25, 2014 after 30 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931071 (1994). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103476: BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX, Ge Medical Systems, LLC (2011) Summary page 7.

## Most influential descendants
- K162990: Optima XR240amx (2016), 3 descendants of its own
- K173602: Optima XR240amx, AutoGrid (2018), 2 descendants of its own
- K182234: Optima XR240amx (2018), 1 descendant of its own
- K210982: AMX Navigate (2021), 0 descendants of its own

## Recalls of this device
- Jun 5, 2026 · Class II · Z-2727-2026: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confir
- Jun 5, 2026 · Class II · Z-2726-2026: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confir
- Nov 25, 2024 · Class II · Z-0811-2025: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bol
- Nov 25, 2024 · Class II · Z-0812-2025: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bol
- Dec 23, 2015 · Class II · Z-0768-2016: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm ass
- Dec 23, 2015 · Class II · Z-0770-2016: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm ass
- Dec 19, 2014 · Class II · Z-1407-2015: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
- Dec 19, 2014 · Class II · Z-1406-2015: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.

## Indications for use
The Optima XR200amx and Optima XR220amx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR220amx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Optima XR200amx and Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The Optima XR200amx and Optima XR220amx are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.

Source page: https://510kreport.com/device/K142383
Methodology: https://510kreport.com/methodology