Cardiovascular Workstation, Model Cws 5000/Cws 3000
by Infimed, Inc. 510(k)
Active
510(k) K992575
Overview
The Cardiovascular Workstation, Models CWS 5000 and CWS 3000, is a digital image processing system designed for cardiovascular imaging. It facilitates the acquisition, review, and analysis of cardiac studies through DICOM transfer, high-resolution analog capture, and direct digital connections. The system supports real-time and slow-motion playback of images, enabling multi-modality comparisons including MRI, CT, nuclear imaging, ultrasound, conventional radiography, and angiography. Its primary function aligns with advanced image processing and PACS-adjacent software for radiological applications.
This workstation is intended for use in clinical settings where cardiovascular imaging is performed, such as hospitals and diagnostic centers. Supplied as a reusable system, it requires appropriate facility infrastructure for installation and operation. The device is classified under the LLZ product code, adhering to Class II special controls for radiological image processing systems. No sterility or single-use specifications are indicated, and MRI safety considerations are not explicitly detailed in the available data. Authorisations include FDA 510(k) clearance under the K992575 submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992575 | Date7 Oct 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Infimed, Inc.
Questions
What is the Infimed CWS 5000/3000 Cardiovascular Workstation used for?
The CWS 5000/3000 is designed for clinical cardiovascular imaging analysis. It processes and reviews cardiac studies across multiple modalities—including MRI, CT, nuclear imaging, ultrasound, radiography, and angiography—via DICOM transfers, analog capture, and direct digital connections. This enables radiologists to perform real-time or slow-motion playback, multi-modality comparisons, and advanced image processing for diagnostic decision-making in hospitals or diagnostic centers.
How is the CWS 5000/3000 supplied and what infrastructure does it require?
The workstation is supplied as a reusable system, not single-use or sterile. It requires installation in a clinical setting with appropriate facility infrastructure, such as compatible IT networks, power supplies, and space for hardware placement. The system integrates with existing PACS (Picture Archiving and Communication Systems) workflows but does not include MRI safety certifications or sterility guarantees.
Are there differences between the CWS 5000 and CWS 3000 models?
The data provided does not specify technical distinctions between the CWS 5000 and CWS 3000 models beyond their classification as part of the same workstation series. Both share identical regulatory clearance (FDA 510(k)) and intended use for cardiovascular imaging analysis. For precise model differences, consult Infimed’s technical documentation or support resources.
What regulatory approval does the CWS 5000/3000 hold?
The Cardiovascular Workstation, Models CWS 5000 and CWS 3000, holds FDA 510(k) clearance under submission K992575, classified under product code LLZ. This clearance follows a traditional review process and is determined as substantially equivalent to a predicate device, with the Radiology Advisory Committee overseeing the submission.
Can the CWS 5000/3000 be reused or does it require sterilization?
The workstation is designed for reusable clinical use and does not have sterility specifications. Unlike single-use devices, it is intended for repeated deployment in healthcare settings, provided it undergoes manufacturer-recommended maintenance and cleaning protocols to ensure functionality and hygiene.