510(k) Report

510(k) · Cleared

Cleared

Multipics (ME-977)

K971154510(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 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1990.

Decided
Jun 25, 1997
Review
89 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K904447 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1992: 1 other ancestorK904447 · Sony Cine Video System Sme-3500 · Sony Medical Electronics Co. · 199019901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K904447 · Sony Cine Video System Sme-3500 · Sony Medical Electronics Co. · 19900
  1. Root · 1 generation backK904447 Sony Cine Video System Sme-3500Sony Medical Electronics Co. · 1990
  2. This deviceK971154 Multipics (ME-977)Merlin Engineering Works, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904447Sony Cine Video System Sme-3500Sony Medical Electronics Co.1990—
0 (this device)K971154Multipics (ME-977)Merlin Engineering Works, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
FIG. 1 — Lineage of K971154, 1990–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K953398Uniscan
Summary page 1
…r(s): ME-977 Common Name: Multiple Picture Digital Scan 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—
*K920550Display 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. K904447 SME-3500 Cine Video System Sony Medical Electronics…
Perkins Mfg. Co.1992—
*K904447Sony Cine Video System Sme-3500
Summary page 1
….1680 (or equivalent) K953398 UniScan Merlin Engineering (a.k.a. Model ME-959) Works, Inc. K920550 IDP-5100 Interventional Perkins Manufacturing Display Processor Co. K904447 SME-3500 Cine Video System Sony Medical Electronics MultiPics (Multiple Picture Scan Converter) is a digital image processing sy…
Sony Medical Electronics Co.1990—

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 3 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

2007: 22008: 12009: 12012: 12015: 12020: 2
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

2007: 12008: 22009: 32010: 92011: 12012: 22013: 42014: 122015: 92016: 32017: 22018: 42019: 22020: 22021: 22022: 62023: 72024: 82025: 16
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—21
20080—12
20090—13
20100—09
20110—01
20120—12
20130—04
20140—012
20150—19
20160—03
20170—02
20180—04
20190—02
20200—22
20210—02
20220—06
20230—07
20240—08
20250—016
20260—0—

What is it indicated for?

The use of MultiPics Is indicated whenever multiple images (2, 3, or 4) are required to be shown together 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.

Also cleared against K953398

4 other devices cite the same predicate.

  • K974882Downscan LTMerlin Engineering Works, Inc. · 1998
  • K971153Splitscreen (ME-975)Merlin Engineering Works, Inc. · 1997
  • K970451Downscan 120Merlin Engineering Works, Inc. · 1997
  • K970450Upscan 120Merlin Engineering Works, Inc. · 1997

More from Merlin Engineering Works, Inc.

8 FDA decisions under this applicant name. See the company

  • K974882Downscan LTMerlin Engineering Works, Inc. · 1998
  • K971153Splitscreen (ME-975)Merlin Engineering Works, Inc. · 1997
  • K970451Downscan 120Merlin Engineering Works, Inc. · 1997
  • K970450Upscan 120Merlin Engineering Works, Inc. · 1997
  • K954211CrispicsMerlin Engineering Works, Inc. · 1995

Recent decisions in LMD

The LMD category page

  • K994329Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
  • K992698Stentor, PageviewStentor, Inc. · 1999
  • K992426Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999
  • K992352ITR2000: Internet Teleradiology, Model Release 1.0Inteleradiology, Inc. · 1999
  • K991537Samsung Raypax SystemSamsung Sds Co., Ltd. · 1999

https://510kreport.com/device/K971154 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971154: Multipics (ME-977).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971154

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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