# K183144: uMC 560i

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Dec 19, 2019 after 401 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K912470 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153244: Cios Fusion, Siemens Medical Solutions USA, Inc. (2016) Summary page 4.

## Indications for use
The uMC 5601 is intended to provide digital imaging of patients during diagnostic and surgical procedures. Examples of clinical application may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinician with clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

Source page: https://510kreport.com/device/K183144
Methodology: https://510kreport.com/methodology