# K974255: CD-R Station and VRS-2000

- Pathway: 510(k) (Traditional)
- Applicant: Electromed Intl., Ltd.
- Decided: Jan 27, 1998 after 75 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- 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 K924708 (1992). 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)
- K924708: Cinenet Cardiac Image Network, Sony Medical Systems (1992) Summary page 1.
- K925961: Optima Archival and Retrieval System, Diagnostic Archives, Inc. (1993) Summary page 1.

## Indications for use
CD writer (CD-R STATION) is intended solely for the engraving of DICOM compliant images from a local area network and the CD reader (VRS-2000) is used for viewing the images either from the CD or directly from a local area network. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R Station and VRS-2000 are used only for running the software and to temporarily buffer the images / reports to and from the CD and local area network.

Source page: https://510kreport.com/device/K974255
Methodology: https://510kreport.com/methodology