# K230039: uOmnispace

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Jul 20, 2023 after 195 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K913770 (1991). 183 ancestors in all.
No later device cites it as a predicate yet.
3 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191040: syngo.via (Version VB40A), Siemens Healthcare GmbH (2019) Summary page 4.

## Indications for use
uOmnispace is a software solution intended to be used for viewing, manipulation, communication and storage of medical images. It allows processing and filming of multimodality DICOM images. It can be used as a stand-alone device or together with a variety of cleared and unmodified software options, and also support to plug in multi-vendor applications which meet interface requirements. uOmnispace is intended to be used by trained professionals, including but not limited to physicians and medical technicians. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Source page: https://510kreport.com/device/K230039
Methodology: https://510kreport.com/methodology