# K243666: uOmniscan

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Jun 17, 2025 after 202 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 7 generations back to K971684 (1997). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232744: syngo Virtual Cockpit (VB10A), Siemens Healthcare GmbH (2023) Summary page 5.

## Indications for use
uOmniscan is a software application for providing real-time communication between remote and local users, providing remote read-only or fully controlled access to connected medical imaging devices, including the ability to remotely initiate MR scans. It is also used for training medical personnel in the use of medical imaging devices. It is a vendor-neutral solution. Access must be authorized by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.

Source page: https://510kreport.com/device/K243666
Methodology: https://510kreport.com/methodology