# K090552: Urocare

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Mar 16, 2009 after 14 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: 4 generations back to K913770 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K014152: Nxstage Cartridge Express, Nxstage Medical, Inc. (2002). Our reading of the summary gave K014152, FDA’s number for Nxstage Cartridge Express (Nxstage Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Volume Viewer Plus Aquarius Workstation”. Kept off the family tree. Summary page 2.

## Indications for use
The UroCARE1.0 is a soft-copy reading workstation intended for clinical review of CT abdominal (urology) images which allows easy acquisition, transmission and review of the medical images and supports HD ROI (High Density Region of Interest) analysis. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis, except in the case of mammography images.

Source page: https://510kreport.com/device/K090552
Methodology: https://510kreport.com/methodology