510(k) Report

510(k) · Cleared

Cleared

X-Ray Vva

K112807510(k) TraditionalCleared Feb 27, 2012153-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

Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological

Cleared on Feb 27, 2012 as substantially equivalent to K993763 (Medis Medical Imaging Systems BV, 1999) and 4 other predicates after a 153-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.

Decided
Feb 27, 2012
Review
153 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K896095 (1990). 17 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor1999: 2 other ancestors2004: 1 other ancestor2001: 1 other ancestor1998: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1991: 1 other ancestor2023: 1 descendant cleared2026: 1 descendant clearedK896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K993761 · Cardiovascular Measurement System - View · Medis Medical Imaging Systems BV · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K993761 · Cardiovascular Measurement System - View · Medis Medical Imaging Systems BV · 1999K982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 19900
  1. Root · 4 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 3 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
  3. 2 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
  4. 1 generation backK993761 Cardiovascular Measurement System - ViewMedis Medical Imaging Systems BV · 1999
  5. This deviceK112807 X-Ray VvaMedis Medical Imaging Systems BV · 2012
  6. Descendant · cites it directly · 1 of its ownK222036 MPXA-2000Medipixel, Inc. · 2023
  7. Descendant · 2 generations on · 0 of its ownK252634 Imagine® Enterprise SuiteSoftlink International Private Limited · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K222036MPXA-2000Medipixel, Inc. · 2023 · cites it directly1descendant
  • K252634Imagine® Enterprise SuiteSoftlink International Private Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K896095Images-on-Call Teleradiology SystemDevices & Services Co.1990—
−3K962699Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V.1996—
−2K982862Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V.1998—
−1K993761Cardiovascular Measurement System - ViewMedis Medical Imaging Systems BV1999—
0 (this device)K112807X-Ray VvaMedis Medical Imaging Systems BV2012—
+1K222036MPXA-2000Medipixel, Inc.2023—
+2K252634Imagine® Enterprise SuiteSoftlink International Private Limited2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199220
199410
199520
199810
199920
200110
200310
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202610
FIG. 1 — Lineage of K112807, 1990–2026Source: 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 21.5 · 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? (5)

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
*K993763Quantitative Analysis of Coronary Angiograms (Qca)
Summary page 1
…Picture Archiving and Communications System Regulation / Procode 21 CFR 892.2050 / LLZ Predicate Devices * The Medis medical imaging system by: QCA-CMS (K993763) " The Medis medical imaging system by: QLV-CMS (K(993765) * The Medis medical imaging system by: QVA-CM[S (1(023970) " The Medis…
Medis Medical Imaging Systems BV1999—
*K993765Quantitative Analysis of Left Ventricular Angiograms (QLV)
Summary page 1
…rocode 21 CFR 892.2050 / LLZ Predicate Devices * The Medis medical imaging system by: QCA-CMS (K993763) " The Medis medical imaging system by: QLV-CMS (K(993765) * The Medis medical imaging system by: QVA-CM[S (1(023970) " The Medis medical imaging system by: UMS-VIEW (K(993761) " The Pie…
Medis Medical Imaging Systems BV1999—
*K023970Quantitative Vascular Angiography - CMS
Summary page 1
…ces * The Medis medical imaging system by: QCA-CMS (K993763) " The Medis medical imaging system by: QLV-CMS (K(993765) * The Medis medical imaging system by: QVA-CM[S (1(023970) " The Medis medical imaging system by: UMS-VIEW (K(993761) " The Pie Medical Imaging by: CAAS (1(052988) Device Description X-R…
Medis Medical Imaging Systems BV2003—
*K993761Cardiovascular Measurement System - View
Summary page 1
…) " The Medis medical imaging system by: QLV-CMS (K(993765) * The Medis medical imaging system by: QVA-CM[S (1(023970) " The Medis medical imaging system by: UMS-VIEW (K(993761) " The Pie Medical Imaging by: CAAS (1(052988) Device Description X-RAY VVA (Vessel and Ventricular Analysis) is image post-proc…
Medis Medical Imaging Systems BV1999—
*K052988CAAS
Summary page 1
…MS (K(993765) * The Medis medical imaging system by: QVA-CM[S (1(023970) " The Medis medical imaging system by: UMS-VIEW (K(993761) " The Pie Medical Imaging by: CAAS (1(052988) Device Description X-RAY VVA (Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantifica…
Pie Medical Imaging BV2005—

Also cleared against K993763: 4 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K222036MPXA-2000Medipixel, Inc.20231

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 22 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
  • 1 of the 17 ancestors has a recall of any class.
  • Of its descendants, K222036 (Medipixel, Inc., 2023) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K993763.

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. 2012, this device’s year, is highlighted.

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?

X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by X-RAY VVA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions…

Read the full statement (117 words)

X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified

results are needed to support the calculations in X-ray angiographic images of the chambers of the heart

and of blood vessels, for use on individual patients with cardiovascular disease.

When the quantified results provided by X-RAY VVA are used in a clinical setting on X-ray images of

an individual patient, they can be used to support the clinical decisions making for the diagnosis of the

patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be

regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the

responsible clinicians.

Indications for use as stated in the FDA summary.

Also cleared against K993763

4 other devices cite the same predicate.

  • K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007
  • K030139The Cardiop-B SystemPaieon, Inc. · 2004
  • K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004
  • K023970Quantitative Vascular Angiography - CMSMedis Medical Imaging Systems BV · 2003

More from Medis Medical Imaging Systems BV

18 FDA decisions under this applicant name. See the company

  • K260523QGuideCT (1.0)Medis Medical Imaging Systems BV · 2026
  • K182611Qangio XA 3DMedis Medical Imaging Systems BV · 2019
  • K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015
  • K073156Qplaque MRMedis Medical Imaging Systems BV · 2008
  • K062386Qangio CTMedis Medical Imaging Systems BV · 2006

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K112807 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112807: X-Ray Vva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112807

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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