# K992575: Cardiovascular Workstation, Model CWS 5000/CWS 3000

- Pathway: 510(k) (Traditional)
- Applicant: Infimed, Inc.
- Decided: Oct 7, 1999 after 66 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: 1 generation back to K960043 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974086: Kodak Digital Science Cardiac Viewer, Eastman Kodak Company (1998) Summary page 1.
- K960043: Kodak Cardiology Digital Archive & Review System, Jamieson Film Co. (1996) Summary page 1.

## Indications for use
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources (including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally (on hard drive, written to CD-R media and/or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.

Source page: https://510kreport.com/device/K992575
Methodology: https://510kreport.com/methodology