510(k) · Cleared

Cleared

mDIXON XD

K143128510(k) TraditionalCleared Mar 20, 2015141-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 Nederlands B.V. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 20, 2015 as substantially equivalent to K102344 (Philips Medical Systems Nederland B.V., 2010) after a 141-day review. Its family tree reaches back 7 generations to 1996. 8 of the 21 devices in its family, counting itself, have a Class I recall.

Decided: Mar 20, 2015
Review: 141 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K962061 (1996). 20 ancestors in all. No later device cites it as a predicate yet. 8 of the 21 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
6 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
5 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
4 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
3 generations backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
2 generations backK072998 Ideal Software Option for GE MR ScannersGe Medical Systems, LLC · 2007
1 generation backK102344 Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T…Philips Medical Systems Nederland B.V. · 2010
This deviceK143128 mDIXON XDPhilips Medical Systems Nederlands B.V. · 2015

Class I recalls in this family

K063559 Achieva, Intera and Panorama 1.0T, Release 2.52 generations back · 2007
K052078 Achieva, Intera and Panorama 1.0 Release 2-Series3 generations back · 2005
K043147 Achieva Family3 generations back · 2005
K041602 Panorama 1.0T3 generations back · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K962061	Magnetic Resonance Diagnostic System	GE Medical Systems	1996	2
−6	K012200	1.5T Infinity Twinspeed MR System	GE Medical Systems	2001	Class I
−5	K013636	Signa Infinity MR System with Excite Technology	GE Medical Systems	2002	Class I
−4	K041476	GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System	Ge Medical Systems, LLC	2004	Class I
−3	K052293	GE 1.5T and 3.0T Signa HDX MR System	Ge Medical Systems, LLC	2005	21
−2	K072998	Ideal Software Option for GE MR Scanners	Ge Medical Systems, LLC	2007	—
−1	K102344	Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR Systems	Philips Medical Systems Nederland B.V.	2010	—
0 (this device)	K143128	mDIXON XD	Philips Medical Systems Nederlands B.V.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2001	3	0
2002	1	0
2003	2	1
2004	1	1
2005	2	2
2007	1	1

FIG. 1 — Lineage of K143128, 1996–2015Source: 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.

8 devices in this family have a Class I recall. 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

Get a 510(k) Report

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
*	K102344	Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR Systems Summary page 5 …ubstantial equivalence is claimed: 1. Primary Predicate Device: mDIXON Manufacturer: Philips Healthcare Predicate Device k#: K102344 2. Reference Devices: MultiVane and e-THRIVE (Ingenia MR System) Manufacturer: Philips Hea…	Philips Medical Systems Nederland B.V.	2010	—
†	K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	2011	20

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (8 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
14 of the 20 ancestors have a recall of any class; 8 have a Class I recall.

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. 2015, this device’s year, is highlighted.

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?

mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.

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/K143128 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143128: mDIXON XD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143128

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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