# K222353: GM85

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Sep 29, 2022 after 56 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K981556 (1998). 58 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220175: GM85, Samsung Electronics Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K242651: GM85 (2024), 0 descendants of its own
- K242478: GF85 (models GF85-3P, GF85-SP) (2024), 0 descendants of its own

## Recalls of this device
- Oct 7, 2025 · Class II · Z-0480-2026: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
- Dec 28, 2023 · Class II · Z-1056-2024: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
- Mar 8, 2023 · Class II · Z-1414-2023: Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm

## Indications for use
The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K222353
Methodology: https://510kreport.com/methodology