# K202350: SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Decided: Jan 6, 2021 after 141 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: 12 generations back to K896095 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200726: AcuityPDR, Radmedix, LLC (2020) Summary page 4.

## Indications for use
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). This device is not intended for mammography.

Source page: https://510kreport.com/device/K202350
Methodology: https://510kreport.com/methodology