510(k) · Cleared

Recalled · Class II · 2026

Achieva R4 1.5T and Achieva R4 3.0T

K110151510(k) TraditionalCleared Mar 22, 201163-day reviewClass II21 CFR 892.1000Recalls 20

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Health Care · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 22, 2011 as substantially equivalent to K063559 (Philips Medical Systems, 2007) and 1 other predicate after a 63-day review. Its family tree reaches back 4 generations to 2003. 4 of the 42 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it. It has been recalled 20 times.

Decided: Mar 22, 2011
Review: 63 days
Class: Class II
Product code: LNH
Recalls: 20
Predicates: 2

Its longest line of descent runs back 4 generations to K031815 (2003). 7 ancestors in all, the oldest K001796 (2000). 34 later devices descend from it, 8 citing it directly. 4 of the 42 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
3 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
2 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
1 generation backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
This deviceK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011
Descendant · cites it directly · 19 of its ownK163116 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · Recalled
Descendant · 2 generations on · 15 of its ownK173079 Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V. · 2018 · Recalled
Descendant · 3 generations on · 13 of its ownK183063 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · Recalled
Descendant · cites it directly · 13 of its ownK143606 MultiBand SENSEPhilips Medical Systems Nethrlands BV · 2015
Descendant · cites it directly · 12 of its ownK162940 MultiBand SENSEPhilips Medical Systems Nederland B.V. · 2016

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2012high 7 (2018) · low 0 (2014)2026

Class I recalls in this family

K063559 Achieva, Intera and Panorama 1.0T, Release 2.5direct predicate · 2007
K043147 Achieva Familydirect predicate · 2005
K052078 Achieva, Intera and Panorama 1.0 Release 2-Series2 generations back · 2005
K041602 Panorama 1.0T2 generations back · 2004

Most influential descendants

Showing 5 of 34 · See all

K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · cites it directly19descendants
K173079Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V. · 2018 · 2 generations on15descendants
K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · 3 generations on13descendants
K143606MultiBand SENSEPhilips Medical Systems Nethrlands BV · 2015 · cites it directly13descendants
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. · 2016 · cites it directly12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K031815	Intera-Sensation Family	Philips Medical Systems	2003	3
−3	K041602	Panorama 1.0T	Philips Medical Systems North America, Inc.	2004	Class I
−2	K052078	Achieva, Intera and Panorama 1.0 Release 2-Series	Philips Medical Systems Nederland B.V.	2005	Class I
−1	K063559	Achieva, Intera and Panorama 1.0T, Release 2.5	Philips Medical Systems	2007	Class I
0 (this device)	K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	2011	—
+1	K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Philips Medical Systems Nederland B.V.	2017	7
+2	K173079	Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4	Philips Medical Systems Nederland B.V.	2018	11
+3	K183063	Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems	Philips Medical Systems Nederland B.V.	2019	25
+1	K143606	MultiBand SENSE	Philips Medical Systems Nethrlands BV	2015	—
+1	K162940	MultiBand SENSE	Philips Medical Systems Nederland B.V.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2005	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	2	0
2016	2	0
2017	1	0
2018	7	0
2019	2	0
2020	2	0
2021	3	0
2022	6	0
2023	3	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K110151, 2003–2026Source: 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.

4 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? (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
*	K063559	Achieva, Intera and Panorama 1.0T, Release 2.5 Summary page 1 …T and ACHIEVA R4 3.OT with enhancements are the successors of their predicate devices ACHIEVA 1.5T and ACHIEVA 3.OT MR systems Release 2.5-series (FDA references K063559, K043 147, K04 1602, K052078 and K013344.) Intended Use: The ACHIEVA R4 1.5T and ACHIEVA R4 3.OT are magnetic resonance…	Philips Medical Systems	2007	Class I
*	K043147	Achieva Family Summary page 1 …IEVA R4 3.OT with enhancements are the successors of their predicate devices ACHIEVA 1.5T and ACHIEVA 3.OT MR systems Release 2.5-series (FDA references K063559, K043 147, K04 1602, K052078 and K013344.) Intended Use: The ACHIEVA R4 1.5T and ACHIEVA R4 3.OT are magnetic resonance diagnostic…	Philips Medical Systems North America Co.	2005	Class I

Also cleared against K063559: 6 other devices →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Philips Medical Systems Nederland B.V.	2017	19
K143606	MultiBand SENSE	Philips Medical Systems Nethrlands BV	2015	13
K162940	MultiBand SENSE	Philips Medical Systems Nederland B.V.	2016	12
K131241	SWIP	Philips Medical Systems Nederland B.V.	2013	5
K151212	Ziostation2	Qi Imaging, LLC	2015	2
K123492	DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)	Philips Medical Systems	2012	1
K190461	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems	Philips Medical Systems Nederland B.V.	2019	0
K153324	Ingenia 1.5T and Ingenia 1.5T S R5.2	Philips Medical Systems Nederlands B.V.	2016	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 28, 2026	Class II	Z-3314-2026	Software design	When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party…
Aug 21, 2026	Class II	Z-3243-2026	Software design	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Aug 11, 2021	Class II	Z-2411-2021	Device Design	When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Jul 30, 2021	Class II	Z-2346-2021	Nonconforming Material/Component	Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Dec 21, 2018	Class II	Z-0924-2019	Unknown/Undetermined by firm	There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018	Class II	Z-0926-2019	Unknown/Undetermined by firm	There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018	Class II	Z-0925-2019	Unknown/Undetermined by firm	There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 1, 2016	Class II	Z-0825-2017	Device Design	Possibility that a patient or user may be exposed to a very small level of touch current.
Aug 21, 2014	Class II	Z-0325-2016	Software Design Change	When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
Jul 27, 2014	Class II	Z-2237-2014	Software design	The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction…
Jun 13, 2014	Class II	Z-1865-2014	Nonconforming Material/Component	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 13, 2014	Class II	Z-1862-2014	Nonconforming Material/Component	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 13, 2014	Class II	Z-1864-2014	Nonconforming Material/Component	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 13, 2014	Class II	Z-1863-2014	Nonconforming Material/Component	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
May 15, 2014	Class II	Z-1827-2014	Device Design	Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
May 15, 2014	Class II	Z-1826-2014	Device Design	Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
May 5, 2014	Class II	Z-0135-2016	Software design	In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
Mar 11, 2014	Class II	Z-1678-2014	Software design	During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in…
Jan 27, 2012	Not classified	Z-1125-2012	Software design	There maybe incorrect values in the diffusion/perfusion maps.
Aug 3, 2011	Not classified	Z-0293-2012	Software design	The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil.

The 5 latest of 20 recalls; the web page lists all.

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
7 of the 7 ancestors have a recall of any class; 4 have a Class I recall.
Of its descendants, K163116 (Philips Medical Systems Nederland B.V., 2017) has gone furthest, with 19 descendants of its own.
6 other devices also cite its predicate K063559.

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. 2011, 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?

The ACHIEVA R4 1.5T and ACHIEVA R14 3.OT are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

In addition, the ACHIEVA R4 1.5T and ACHIEVA R4 3.OT devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110151 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110151: Achieva R4 1.5T and Achieva R4 3.0T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110151

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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