510(k) Report

510(k) · Cleared

Cleared

Prowin

K050376510(k) TraditionalCleared Apr 7, 200552-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

Medical Technologies International, Inc. · LLZ System, Image Processing, Radiological

Cleared on Apr 7, 2005 as substantially equivalent to K040686 (Intelligence IN Medical Technologies, 2004) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 2002. 22 later devices descend from it.

Decided
Apr 7, 2005
Review
52 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K021966 (2002). 22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2012: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared2020: 2 descendants cleared2018: 3 descendants cleared2022: 3 descendants cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 4 descendants cleared2023: 1 descendant cleared2026: 1 descendant clearedK021966 · Q Lab Software · Advanced Technology Laboratories, Inc. · 2002K030223 · Sonocalc · Sonometric Health, LLC · 2003 · recalledK040686 · M'ath STD · Intelligence IN Medical Technologies · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 2 descendants9 generations forward: 2 descendants10 generations forward: 2 descendants K040686 · M'ath STD · Intelligence IN Medical Technologies · 2004K030223 · Sonocalc · Sonometric Health, LLC · 2003 · recalledK021966 · Q Lab Software · Advanced Technology Laboratories, Inc. · 20020+5+10
  1. Root · 3 generations backK021966 Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
  2. 2 generations backK030223 SonocalcSonometric Health, LLC · 2003 · Recalled
  3. 1 generation backK040686 M'ath STDIntelligence IN Medical Technologies · 2004
  4. This deviceK050376 ProwinMedical Technologies International, Inc. · 2005
  5. Descendant · cites it directly · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
  6. Descendant · 2 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
  7. Descendant · 3 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
  8. Descendant · 4 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  9. Descendant · 4 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008: 22012: 12013: 12017: 12018: 32020: 22021: 12022: 32023: 12024: 42025: 22026: 1
2008high 4 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all
  • K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · cites it directly21descendants
  • K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on19descendants
  • K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 3 generations on12descendants
  • K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 4 generations on11descendants
  • K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K021966Q Lab SoftwareAdvanced Technology Laboratories, Inc.2002—
−2K030223SonocalcSonometric Health, LLC20031
−1K040686M'ath STDIntelligence IN Medical Technologies2004—
0 (this device)K050376ProwinMedical Technologies International, Inc.2005—
+1K073156Qplaque MRMedis Medical Imaging Systems BV2008—
+2K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.2012—
+3K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation2017—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation2018—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201210
201310
201710
201830
202020
202110
202230
202310
202440
202520
202610
FIG. 1 — Lineage of K050376, 2002–2026Source: 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), 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 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 21.6 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K040686M'ath STD
Summary page 1
…inTM's measurement of IMT is substantially equivalent to other legally marketed products, specifically Intelligence in Medical TM Technologies' M'Ath® Std (K040686), SonoMetric Health's SonoCalc Tm (K030223…
Intelligence IN Medical Technologies2004—
*K030223Sonocalc
Summary page 1
…cal TM Technologies' M'Ath® Std (K040686), SonoMetric Health's SonoCalc Tm (K030223) and ATL Ultrasound's (d.b.a. Philips Ultrasound) QLAB software package (K021966) when the latter is used for the automate…
Sonometric Health, LLC20031
*K021966Q Lab Software
Summary page 1
…Tm (K030223) and ATL Ultrasound's (d.b.a. Philips Ultrasound) QLAB software package (K021966) when the latter is used for the automated measurement of carotid intima-media thickness. 4. Device Description…
Advanced Technology Laboratories, Inc.2002—

Also cleared against K040686: 1 other device →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K073156Qplaque MRMedis Medical Imaging Systems BV200821

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?

  • The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 8 months on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K073156 (Medis Medical Imaging Systems BV, 2008) has gone furthest, with 21 descendants of its own.
  • 1 other device also cites its predicate K040686.

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—

What is it indicated for?

The Prowin TM software program is a Windows-based application used on a personal computer intended for viewing carotid ultrasound images and measuring arterial wall thickness. It is specifically indicated for the measurement of carotid artery far and near wall intima-media thickness (IMT) from images obtained from an ultrasound system. A physician may use this information in conjunction with other medical data in the assessment of a patient's cardiovascular risk.

Indications for use as stated in the FDA summary.

Also cleared against K040686

1 other device cites the same predicate.

  • K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012

More from Medical Technologies International, Inc.

3 FDA decisions under this applicant name. See the company

  • K935131Family First Aid KitMedical Technologies International, Inc. · 1994
  • K850799Rinse Machine KR-4 Kidney Rinse-4Medical Technologies International, Inc. · 1985

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K050376 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050376: Prowin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050376

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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