510(k) Report

510(k) · Cleared

Cleared

Scribe (TM) Diagnostic Imaging Workstation

K945428510(k) TraditionalCleared Mar 9, 1995125-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Multi-Dimensional Imaging, Inc. · LLZ System, Image Processing, Radiological

Cleared on Mar 9, 1995 after a 125-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 208 later devices descend from it.

Decided
Mar 9, 1995
Review
125 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

208 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2008: 11 descendants cleared1998: 5 descendants cleared1999: 1 descendant cleared2004: 3 descendants cleared2019: 5 descendants cleared2007: 9 descendants cleared2005: 2 descendants cleared2006: 4 descendants cleared2018: 11 descendants cleared2009: 6 descendants cleared2010: 5 descendants cleared2023: 13 descendants cleared2021: 8 descendants cleared2020: 7 descendants cleared2002: 2 descendants cleared2013: 7 descendants cleared2012: 9 descendants cleared2015: 10 descendants cleared2017: 6 descendants cleared2011: 6 descendants cleared2026: 13 descendants cleared2022: 13 descendants cleared2024: 19 descendants cleared2014: 8 descendants cleared2016: 3 descendants cleared2025: 21 descendants cleared1995200020052010201520202025
  1. This deviceK945428 Scribe (TM) Diagnostic Imaging WorkstationMulti-Dimensional Imaging, Inc. · 1995
  2. Descendant · cites it directly · 207 of its ownK960911 Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996
  3. Descendant · 2 generations on · 166 of its ownK990426 Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999
  4. Descendant · 3 generations on · 112 of its ownK043111 Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004
  5. Descendant · 4 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
  6. Descendant · 4 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled

Showing 5 of 208 descendants. See all descendants

Descendants cleared per year

1996: 11998: 51999: 12002: 22004: 32005: 22006: 42007: 92008: 112009: 62010: 52011: 62012: 92013: 72014: 82015: 102016: 32017: 62018: 112019: 52020: 72021: 82022: 132023: 132024: 192025: 212026: 13
1996high 21 (2025) · low 0 (1997)2026

Most influential descendants

Showing 5 of 208 · See all
  • K960911Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996 · cites it directly207descendants
  • K990426Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on166descendants
  • K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004 · 3 generations on112descendants
  • K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 4 generations on111descendants
  • K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 4 generations on82descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945428Scribe (TM) Diagnostic Imaging WorkstationMulti-Dimensional Imaging, Inc.1995—
+1K960911Netra Workstation System & Netra MD SoftwareScimage, Inc.1996—
+2K990426Calcium ScoringSiemens Medical Solutions USA, Inc.1999—
+3K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C2004—
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061
+4K071331Vitrea Version 4.0Vital Images, Inc.20071

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199850
199910
200220
200430
200520
200640
200790
2008110
200960
201050
201160
201290
201370
201480
2015100
201630
201760
2018110
201950
202070
202180
2022130
2023130
2024190
2025210
2026130
FIG. 1 — Lineage of K945428, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (208)

See all 208

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960911Netra Workstation System & Netra MD SoftwareScimage, Inc.1996207

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, K960911 (Scimage, Inc., 1996) has gone furthest, with 207 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

Recent decisions in LLZ

The LLZ category page

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https://510kreport.com/device/K945428 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945428: Scribe (TM) Diagnostic Imaging Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945428

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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