510(k) · Cleared

Cleared

Splitscreen (ME-975)

K971153510(k) TraditionalCleared Jun 25, 199789-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 Jun 25, 1997 as substantially equivalent to K953398 (Merlin Engineering Works, Inc., 1995) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1992.

Decided: Jun 25, 1997
Review: 89 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K920550 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK920550 Display Processor - Model IDP5100Perkins Mfg. Co. · 1992
This deviceK971153 Splitscreen (ME-975)Merlin Engineering Works, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920550	Display Processor - Model IDP5100	Perkins Mfg. Co.	1992	—
0 (this device)	K971153	Splitscreen (ME-975)	Merlin Engineering Works, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K971153, 1992–1997Source: 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? (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
*	K953398	Uniscan Summary page 1 …r(s): ME-975 Common Name: Multiple Picture Digital Sean Converter. Classification (A component of) stationary x-ray system, per 21 Name: CFR 892.1680 (or equivalent) K953398 UniScan Merlin Engineering (a.k.a. Model ME-959) Works, Inc. K920550 IDP-5100 Interventional Perkins Manufacturing Display Proce…	Merlin Engineering Works, Inc.	1995	—
*	K920550	Display Processor - Model IDP5100 Summary page 1 …lassification (A component of) stationary x-ray system, per 21 Name: CFR 892.1680 (or equivalent) K953398 UniScan Merlin Engineering (a.k.a. Model ME-959) Works, Inc. K920550 IDP-5100 Interventional Perkins Manufacturing Display Processor Co. SplitScreen is a digital image processing systems that can d…	Perkins Mfg. Co.	1992	—

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?

None of the 2 ancestors has a 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 SplitScreen is indicated whenever two images are required to be shown together side-by-side in a single image/display, and a high-line rate (e.g., 1049 lines @ 30 frames/sec. or 1249 lines @ 25 fps) video signal is required. Examples include conversion / combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and/or 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, disk, or other apparatus requiring a high-line rate video 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/K971153 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971153: Splitscreen (ME-975).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971153

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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