510(k) · Cleared

Cleared

Mri- Flow Analytical Software Package

K994282510(k) TraditionalCleared Mar 2, 200073-day reviewClass II21 CFR 892.1000

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 · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 2, 2000 as substantially equivalent to K924605 (General Electric Co., 1993) after a 73-day review. Its family tree reaches back 1 generation to 1993. 73 later devices descend from it.

Decided: Mar 2, 2000
Review: 73 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924605 (1993). 73 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK924605 Magnetic Resonance Diagnostic AccessoryGeneral Electric Co. · 1993
This deviceK994282 Mri- Flow Analytical Software PackageMedis Medical Imaging Systems BV · 2000
Descendant · cites it directly · 22 of its ownK031927 GE Delta Software Option for MriGE Medical Systems · 2003
Descendant · 2 generations on · 21 of its ownK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
Descendant · cites it directly · 21 of its ownK091262 MR Cardiac Function AnalysisZiosoft, Inc. · 2009
Descendant · 2 generations on · 20 of its ownK103465 Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011
Descendant · 3 generations on · 19 of its ownK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2003high 10 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 73 · See all

K031927GE Delta Software Option for MriGE Medical Systems · 2003 · cites it directly22descendants
K121762Cardiac VXGe Medical Systems, LLC · 2013 · 2 generations on21descendants
K091262MR Cardiac Function AnalysisZiosoft, Inc. · 2009 · cites it directly21descendants
K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011 · 2 generations on20descendants
K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924605	Magnetic Resonance Diagnostic Accessory	General Electric Co.	1993	—
0 (this device)	K994282	Mri- Flow Analytical Software Package	Medis Medical Imaging Systems BV	2000	—
+1	K031927	GE Delta Software Option for Mri	GE Medical Systems	2003	—
+2	K121762	Cardiac VX	Ge Medical Systems, LLC	2013	1
+1	K091262	MR Cardiac Function Analysis	Ziosoft, Inc.	2009	—
+2	K103465	Synapse 3D Cardiac Tools	Fujifilm Medical Systems U.S.A, Inc.	2011	—
+3	K140587	MR-CT Vva	Medis Medical Imaging Systems BV	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2008	1	0
2009	4	0
2011	3	0
2012	2	0
2013	3	0
2014	1	0
2015	2	0
2016	2	0
2017	3	0
2018	8	0
2019	1	0
2020	5	0
2021	5	0
2022	7	0
2023	4	0
2024	10	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K994282, 1993–2026Source: 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 LNH? 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 LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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? (1)

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
*	K924605	Magnetic Resonance Diagnostic Accessory Summary page 1 …Common Name : FLOW Device Class. Name : System, Image Processing; Regulation Number :21 CFR 892.2050 (90 LLZ; Class II) 3) Predicate Device : General Electric: 510(k) K924605 4) Description of the device: FLOW is a state-of-the-art analytical software tool designed for UNIX as well as Linux platforms.…	General Electric Co.	1993	—

Also cleared against K924605: 2 other devices →

What descends from it? (73)

See all 73

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

Number	Device	Applicant	Decided	Descendants
K031927	GE Delta Software Option for Mri	GE Medical Systems	2003	22
K091262	MR Cardiac Function Analysis	Ziosoft, Inc.	2009	21
K090833	Segment	Medviso	2009	13
K082628	CMR42 Cardiac Mri Imaging System, 2.1.23	Circle Cardiovascular Imaging, Inc.	2008	12
K090155	Caas MR Flow 1.0	Pie Medical Imaging BV	2009	2
K102534	Aze Virtualplace-MR Flow Analysis Software	Aze, Ltd.	2011	0
K082526	Cardio Vue Quantitative Analysis (CVQ)	Mri Cardiac Services, Incorporated	2009	0

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?

Its one ancestor has no recall.
Of its descendants, K031927 (GE Medical Systems, 2003) has gone furthest, with 22 descendants of its own.
2 other devices also cite its predicate K924605.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

FLOW has been developed for the objective and reproducible analysis of velocity-encoded cine MR imaging studies of arterial vessels and heart valves. FLOW software package enables to semi-automatically calculate and display all parameters: mean velocity (also minimum, maximum and standard deviation) and volume flow through region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output. Although therefore a qualified physician these parameters may be useful in establishing the determination of a diagnosis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K994282 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994282: Mri- Flow Analytical Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994282

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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