# K031638: Cardio Vascular Information Enhanced Workstation

- Pathway: 510(k) (Abbreviated)
- Applicant: Electromed Imaging, Inc.
- Decided: Jul 21, 2003 after 55 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 K950279 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000474: View NT, Electromed Intl., Ltd. (2000)
- K023557: Centricity Pacs Plus, GE Medical Systems (2002)
- K992666: Video Plus System, Series 95000, Camtronics, Ltd. (1999) Summary page 2.
- K992259: Echocardiography System Series 95000, Camtronics, Ltd. (1999) Summary page 2.
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002)

## Indications for use
The CVIEWM is a high performance, digital, cardiac image viewer. The System supports DICOM 3.x and higher cardiac and angio images and displays them in their original dynamic mode. The CVIEW accepts images from DICOM 3.x CDs or can be configured to read DICOM 3 images from a DICOM Archive Server. The CVIEW allows immediate playback of images from any patient stored on the system and burning CDs in the DICOM part 10 - file format. It represents the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.

Source page: https://510kreport.com/device/K031638
Methodology: https://510kreport.com/methodology