# K253058: Portable DR Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd.
- Decided: Jun 18, 2026 after 269 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: 13 generations back to K896095 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202353: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System, Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (2020) Summary page 5.

## Indications for use
The Portable DR Imaging System 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 extremities. This device is not intended for mammography. This device is only intended for adults, not for paediatric application. This device is only suitable for stand-mounted use in hospital shielded rooms.

Source page: https://510kreport.com/device/K253058
Methodology: https://510kreport.com/methodology