# K220700: Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

- Pathway: 510(k) (Traditional)
- Applicant: Yian Medical Technology (Haining) Co., Ltd.
- Decided: May 4, 2022 after 55 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: 4 generations back to K040046 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200976: SR-8230, SR-8230S Portable X-ray Unit, Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (2020) Summary page 6.

## Indications for use
The Heart5R-110, Heart3R-110 are Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population 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 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 intended for mammography.

Source page: https://510kreport.com/device/K220700
Methodology: https://510kreport.com/methodology