510(k) · Cleared

Cleared

Infinion Software Features

K024066510(k) TraditionalCleared Feb 4, 200357-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

Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 4, 2003 as substantially equivalent to K003573 (Ge Medical Systems, Inc., 2001) after a 57-day review. Its family tree reaches back 1 generation to 2001.

Decided: Feb 4, 2003
Review: 57 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003573 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003573 Diffusion Tensor Imaging OptionGe Medical Systems, Inc. · 2001
This deviceK024066 Infinion Software FeaturesPhilips Medical Systems (Cleveland), Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003573	Diffusion Tensor Imaging Option	Ge Medical Systems, Inc.	2001	—
0 (this device)	K024066	Infinion Software Features	Philips Medical Systems (Cleveland), Inc.	2003	—

FIG. 1 — Lineage of K024066, 2001–2003Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003573	Diffusion Tensor Imaging Option Summary page 2 …rly Marconi's) Infinion 1.5T MR Imaging System, the Philips Intera (R7.5) Software Package, and the Diffusion Tensor offered by General Electric in K003573. Substantial Eauivalence Chart STIC FIELD…	Ge Medical Systems, Inc.	2001	—
*	—	Philips (formerly Marconi's) Infinion 1.5T MR Imaging System Named without a submission number			—
*	—	Philips Intera (R7.5) Software Package Named without a submission number			—
†	K003853	Infinion 1.5T MR Imaging System, Model Mri 100	Philips Medical Systems (Cleveland), Inc.	2001	6
†	K001796	Gyroscan Intera (R7.5)	Philips Medical Systems North America, Inc.	2000	4

Also cleared against K003573: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K003573.

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?

The Infinion Software Features does not change the existing indications as defined below. The Infinion 1.5T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole…

Read the full statement (136 words)

The Infinion Software Features does not change the existing indications as defined below.

The Infinion 1.5T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Diffusion tensor imaging produced magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion tensor imaging can be used to image the directional dependence of the diffusion coefficient in tissue with restricted diffusion from tissues with normal diffusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024066: Infinion Software Features.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024066

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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