# K182207: TR90BH

- Pathway: 510(k) (Traditional)
- Applicant: Minxray, Inc.
- Decided: Dec 14, 2018 after 121 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040046 (2004). 2 ancestors in all.
16 later devices descend from it; 9 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153059: HF1202H PowerPlus Portable X-ray Equipment, Minxray, Inc. (2016) Summary page 4.

## Most influential descendants
- K212144: Remex KA6 (2021), 3 descendants of its own
- K222896: AirRay (2022), 1 descendant of its own
- K210479: IMPACT and X-Ranger (2021), 1 descendant of its own
- K200637: SR-8100 Portable X-ray Unit (2020), 1 descendant of its own
- K200976: SR-8230, SR-8230S Portable X-ray Unit (2020), 1 descendant of its own

## Indications for use
The TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

Source page: https://510kreport.com/device/K182207
Methodology: https://510kreport.com/methodology