# K200637: SR-8100 Portable X-ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Decided: Jul 9, 2020 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: 3 generations back to K040046 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182207: TR90BH, Minxray, Inc. (2018) Summary page 5.

## Most influential descendants
- K241996: ULTRA 1040 (2025), 0 descendants of its own

## Indications for use
The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities. The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. The device may be used for imaging of the chest when used without a grid. This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.

Source page: https://510kreport.com/device/K200637
Methodology: https://510kreport.com/methodology