510(k) · Cleared

Cleared

Downscan LT

K974882510(k) TraditionalCleared May 22, 1998143-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

Merlin Engineering Works, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on May 22, 1998 as substantially equivalent to K953398 (Merlin Engineering Works, Inc., 1995) after a 143-day review. Its family tree reaches back 1 generation to 1995.

Decided: May 22, 1998
Review: 143 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K953398 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK953398 UniscanMerlin Engineering Works, Inc. · 1995
This deviceK974882 Downscan LTMerlin Engineering Works, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953398	Uniscan	Merlin Engineering Works, Inc.	1995	—
0 (this device)	K974882	Downscan LT	Merlin Engineering Works, Inc.	1998	—

FIG. 1 — Lineage of K974882, 1995–1998Source: 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K953398	Uniscan Summary page 1 …de Name: DownScan LT Model Number: ME-509 Common Name: Video Scan Converter (or Digital Scan Converter) Classiftcation Image Processing System Name: ) Device(s) to which K953398 UniScan Merlin Engineering Works substantial equivalence yo70451 pownScan 120 Merlin Engineering Works is claimed: Description…	Merlin Engineering Works, Inc.	1995	—
Kept off the family tree	K970451	FDA’s K970451 is Downscan 120 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Merlin Engineering Works, Inc.	1997	—

Also cleared against K953398: 4 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.
4 other devices also cite its predicate K953398.

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 use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal (30 or 25 frames/second) is required. Examples include conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, or disk recorders, or other apparatus requiring a standard frame rate signal.

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/K974882 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974882: Downscan LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974882

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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