510(k) · Cleared

Cleared

Aze Virtualplace-MR Flow Analysis Software

K102534510(k) TraditionalCleared May 24, 2011263-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

Aze, Ltd. · LLZ System, Image Processing, Radiological

Cleared on May 24, 2011 as substantially equivalent to K994282 (Medis Medical Imaging Systems BV, 2000) and 1 other predicate after a 263-day review. Its family tree reaches back 4 generations to 1994.

Decided: May 24, 2011
Review: 263 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K940172 (1994). 6 ancestors in all, the oldest K924605 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
3 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
2 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
1 generation backK082628 CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc. · 2008
This deviceK102534 Aze Virtualplace-MR Flow Analysis SoftwareAze, Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K940172	Cardiovascular Measurement System-CMS	Medis Medical Imaging Systems, Inc.	1994	—
−3	K993765	Quantitative Analysis of Left Ventricular Angiograms (QLV)	Medis Medical Imaging Systems BV	1999	—
−2	K994283	Mri- Magnetic Resonance Analytical Software System	Medis Medical Imaging Systems BV	2000	—
−1	K082628	CMR42 Cardiac Mri Imaging System, 2.1.23	Circle Cardiovascular Imaging, Inc.	2008	—
0 (this device)	K102534	Aze Virtualplace-MR Flow Analysis Software	Aze, Ltd.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
2000	1	0

FIG. 1 — Lineage of K102534, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K994282	Mri- Flow Analytical Software Package Summary page 1 …ion Name: System, Image Processing, Radiology CFR Reference: 21 CER 892.2050 Class: [I Product Code: 90 LLZ Predicate Devices MRI-FLOW analytical software package (K994282) from MEDIS medical imaging systems B.V and cmr 4 2 Cardiac MR Software (K082628) from Circle Cardiovascular Imaging, Inc. Dev…	Medis Medical Imaging Systems BV	2000	—
*	K082628	CMR42 Cardiac Mri Imaging System, 2.1.23 Summary page 1 …ss: [I Product Code: 90 LLZ Predicate Devices MRI-FLOW analytical software package (K994282) from MEDIS medical imaging systems B.V and cmr 4 2 Cardiac MR Software (K082628) from Circle Cardiovascular Imaging, Inc. Device Description AZE VirtualPlace - MR Flow Analysis software is an optional post-…	Circle Cardiovascular Imaging, Inc.	2008	—

Also cleared against K994282: 6 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?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
None of the 6 ancestors has a recall.
6 other devices also cite its predicate K994282.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

AZE VirtualPlace - MR Flow Analysis software option for use with AZE VirtualPlace workstation is intended for post-processing of DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves. The MR Flow Analysis software calculates and displays the following parameters: mean/minimum/maximum and standard deviation of blood velocity in the selected region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output, and provides graphs of the velocity and volume. These parameters may be useful for a trained physician in supporting the determination of a diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102534 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102534: Aze Virtualplace-MR Flow Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102534

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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