510(k) · Cleared

Cleared

Ris Scanview System (RSVS)

K970641510(k) TraditionalCleared May 2, 199771-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

Radiology Information Systems, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on May 2, 1997 as substantially equivalent to K936179 (Line Imaging Systems, 1994) after a 71-day review. Its family tree reaches back 1 generation to 1994.

Decided: May 2, 1997
Review: 71 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K936179 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK936179 Winrad Teleradiology SystemLine Imaging Systems · 1994
This deviceK970641 Ris Scanview System (RSVS)Radiology Information Systems, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K936179	Winrad Teleradiology System	Line Imaging Systems	1994	—
0 (this device)	K970641	Ris Scanview System (RSVS)	Radiology Information Systems, Inc.	1997	—

FIG. 1 — Lineage of K970641, 1994–1997Source: 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? (1)

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
*	K936179	Winrad Teleradiology System Summary page 1 …munication Systemn (PACS). Proposed 892.2050 classifies PACS in Class I1. 3.0 Predicate Device The RSVS is substantially equivalent to the WinRad Teleradiology System (K936179) manufactured by Line Imaging Systems. 4.0 RIS ScanView System The RIS ScanView System (RSVS) is a DICOM 3.0 complisat secondary…	Line Imaging Systems	1994	—

Also cleared against K936179: 3 other devices →

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?

Its one ancestor has no recall.
3 other devices also cite its predicate K936179.

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?

The RSVS is intended for use as an image display and keyboard entry node on a DICOM 3.0 network. It’s principal anticipated functions are to merge bitmap images from image sources with keyboard input patient information to form DICOM 3.0 patient image files and provide quality assurance review of such files.

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/K970641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970641: Ris Scanview System (RSVS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970641

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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