510(k) · Cleared

Cleared

CD-R Station and VRS-2000

K974255510(k) TraditionalCleared Jan 27, 199875-day reviewClass I21 CFR 892.2020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Electromed Intl., Ltd. · LMD System, Digital Image Communications, Radiological

Cleared on Jan 27, 1998 as substantially equivalent to K924708 (Sony Medical Systems, 1992) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1992.

Decided: Jan 27, 1998
Review: 75 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K924708 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924708 Cinenet Cardiac Image NetworkSony Medical Systems · 1992
This deviceK974255 CD-R Station and VRS-2000Electromed Intl., Ltd. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924708	Cinenet Cardiac Image Network	Sony Medical Systems	1992	—
0 (this device)	K974255	CD-R Station and VRS-2000	Electromed Intl., Ltd.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K974255, 1992–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K924708	Cinenet Cardiac Image Network Summary page 1 …ac images PROPRIETARY NAME: CD-R STATION & VRS-2000 PREVIOUSLY MARKETED DEVICE TO Sony Medical System’s WHICH SUBSTANTIAL EQUIVALENCE “Cinenet Cardiac Image Network” (K924708) IS BEING CLAIMED: and Diagnostic Archive’s “Cardiac Image Management System (CIMS)” (K925961) The CD-R STATION & VRS-2000 rep…	Sony Medical Systems	1992	—
*	K925961	Optima Archival and Retrieval System Summary page 1 …System’s WHICH SUBSTANTIAL EQUIVALENCE “Cinenet Cardiac Image Network” (K924708) IS BEING CLAIMED: and Diagnostic Archive’s “Cardiac Image Management System (CIMS)” (K925961) The CD-R STATION & VRS-2000 represents the first generation of Electromed International’s CD writer and CD reader stations of d…	Diagnostic Archives, Inc.	1993	—
†	K971176	View Archiving Station	Electromed Intl., Ltd.	1997	—

Also cleared against K924708: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K924708.

How does its category compare?

All LMD devices

LMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMD

FDA has decided no LMD device since 2007.

Median 510(k) review, days · LMD

Too few LMD 510(k)s in any year since 2007 to give a median.

Recalls per year · LMD

2in 2020

2007high 2 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMD

16in 2025

2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	1	2
2009	—	1	3
2010	—	0	9
2011	—	0	1
2012	—	1	2
2013	—	0	4
2014	—	0	12
2015	—	1	9
2016	—	0	3
2017	—	0	2
2018	—	0	4
2019	—	0	2
2020	—	2	2
2021	—	0	2
2022	—	0	6
2023	—	0	7
2024	—	0	8
2025	—	0	16
2026	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974255 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974255: CD-R Station and VRS-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974255

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026