510(k) Report

510(k) · Cleared

Cleared

Uniscan

K953398510(k) TraditionalCleared Oct 6, 199578-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 Oct 6, 1995 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Oct 6, 1995
Review
78 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
0

5 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1997: 4 descendants cleared1998: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953398 UniscanMerlin Engineering Works, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK974882 Downscan LTMerlin Engineering Works, Inc. · 1998
  3. Descendant · cites it directly · 0 of its ownK971154 Multipics (ME-977)Merlin Engineering Works, Inc. · 1997
  4. Descendant · cites it directly · 0 of its ownK971153 Splitscreen (ME-975)Merlin Engineering Works, Inc. · 1997
  5. Descendant · cites it directly · 0 of its ownK970451 Downscan 120Merlin Engineering Works, Inc. · 1997
  6. Descendant · cites it directly · 0 of its ownK970450 Upscan 120Merlin Engineering Works, Inc. · 1997

Most influential descendants

Showing 5 of 5 · See all
  • K974882Downscan LTMerlin Engineering Works, Inc. · 1998 · cites it directly0descendants
  • K971154Multipics (ME-977)Merlin Engineering Works, Inc. · 1997 · cites it directly0descendants
  • K971153Splitscreen (ME-975)Merlin Engineering Works, Inc. · 1997 · cites it directly0descendants
  • K970451Downscan 120Merlin Engineering Works, Inc. · 1997 · cites it directly0descendants
  • K970450Upscan 120Merlin Engineering Works, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953398UniscanMerlin Engineering Works, Inc.1995—
+1K974882Downscan LTMerlin Engineering Works, Inc.1998—
+1K971154Multipics (ME-977)Merlin Engineering Works, Inc.1997—
+1K971153Splitscreen (ME-975)Merlin Engineering Works, Inc.1997—
+1K970451Downscan 120Merlin Engineering Works, Inc.1997—
+1K970450Upscan 120Merlin Engineering Works, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199740
199810
FIG. 1 — Lineage of K953398, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974882Downscan LTMerlin Engineering Works, Inc.19980
K971154Multipics (ME-977)Merlin Engineering Works, Inc.19970
K971153Splitscreen (ME-975)Merlin Engineering Works, Inc.19970
K970451Downscan 120Merlin Engineering Works, Inc.19970
K970450Upscan 120Merlin Engineering Works, Inc.19970

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?

  • Of its descendants, K974882 (Merlin Engineering Works, Inc., 1998) has gone furthest, with 0 descendants of its own.

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—

More from Merlin Engineering Works, Inc.

8 FDA decisions under this applicant name. See the company

  • K974882Downscan LTMerlin Engineering Works, Inc. · 1998
  • K971154Multipics (ME-977)Merlin Engineering Works, Inc. · 1997
  • K971153Splitscreen (ME-975)Merlin Engineering Works, Inc. · 1997
  • K970451Downscan 120Merlin Engineering Works, Inc. · 1997
  • K970450Upscan 120Merlin Engineering Works, Inc. · 1997

Recent decisions in LMD

The LMD category page

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  • K992426Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999
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  • K991537Samsung Raypax SystemSamsung Sds Co., Ltd. · 1999

https://510kreport.com/device/K953398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953398: Uniscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953398

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026