510(k) · Cleared

Recalled · Class I · 2026

Achieva, Intera and Panorama 1.0T, Release 2.5

K063559510(k) TraditionalCleared Jan 4, 200738-day reviewClass II21 CFR 892.1000Recalls 10 (1 Class I)

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

Philips Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jan 4, 2007 as substantially equivalent to K043147 (Philips Medical Systems North America Co., 2005) and 3 other predicates after a 38-day review. Its family tree reaches back 3 generations to 2003. 4 of the 60 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it. It has been recalled 10 times, including a Class I recall.

Decided: Jan 4, 2007
Review: 38 days
Class: Class II
Product code: LNH
Recalls: 10 (1 Class I)
Predicates: 4

Its longest line of descent runs back 3 generations to K031815 (2003). 6 ancestors in all, the oldest K001796 (2000). 53 later devices descend from it, 7 citing it directly. 4 of the 60 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
2 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
1 generation backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
This deviceK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007
Descendant · cites it directly · 34 of its ownK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · Recalled
Descendant · 2 generations on · 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 · 3 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 · 4 generations on · 13 of its ownK183063 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · Recalled
Descendant · 2 generations on · 13 of its ownK143606 MultiBand SENSEPhilips Medical Systems Nethrlands BV · 2015

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2010high 9 (2018) · low 0 (2014)2026

Class I recalls in this family

K052078 Achieva, Intera and Panorama 1.0 Release 2-Seriesdirect predicate · 2005
K043147 Achieva Familydirect predicate · 2005
K041602 Panorama 1.0Tdirect predicate · 2004

Most influential descendants

Showing 5 of 53 · See all

K110151Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · cites it directly34descendants
K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · 2 generations on19descendants
K173079Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V. · 2018 · 3 generations on15descendants
K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · 4 generations on13descendants
K143606MultiBand SENSEPhilips Medical Systems Nethrlands BV · 2015 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K031815	Intera-Sensation Family	Philips Medical Systems	2003	3
−2	K041602	Panorama 1.0T	Philips Medical Systems North America, Inc.	2004	Class I
−1	K052078	Achieva, Intera and Panorama 1.0 Release 2-Series	Philips Medical Systems Nederland B.V.	2005	Class I
0 (this device)	K063559	Achieva, Intera and Panorama 1.0T, Release 2.5	Philips Medical Systems	2007	—
+1	K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	2011	20
+2	K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Philips Medical Systems Nederland B.V.	2017	7
+3	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
+4	K183063	Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems	Philips Medical Systems Nederland B.V.	2019	25
+2	K143606	MultiBand SENSE	Philips Medical Systems Nethrlands BV	2015	—

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
2010	2	0
2011	3	0
2012	1	0
2013	1	0
2015	4	0
2016	3	0
2017	3	0
2018	9	0
2019	2	0
2020	3	0
2021	4	0
2022	8	0
2023	5	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K063559, 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

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What was it cleared against? (4)

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
*	K043147	Achieva Family Summary page 1 …, INTERA and PANORAMA 1.0T Release 2.5-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA LOT release 2-series. (FDA references K043147, K041602, K052078 and KO 13344). Indications for use: The ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series are…	Philips Medical Systems North America Co.	2005	Class I
*	K041602	Panorama 1.0T Summary page 1 …and PANORAMA 1.0T Release 2.5-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA LOT release 2-series. (FDA references K043147, K041602, K052078 and KO 13344). Indications for use: The ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series are…	Philips Medical Systems North America, Inc.	2004	Class I
*	K052078	Achieva, Intera and Panorama 1.0 Release 2-Series Summary page 1 …AMA 1.0T Release 2.5-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA LOT release 2-series. (FDA references K043147, K041602, K052078 and KO 13344). Indications for use: The ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series are magnetic…	Philips Medical Systems Nederland B.V.	2005	Class I
*	K013344	Intera I/T	Philips Medical Systems North America Co.	2001	2

Also cleared against K043147: 5 other devices →

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	2011	34
K100836	Clearpoint System	Surgivision, Inc.	2010	12
K181892	Ziostation2	Ziosoft, Inc.	2018	1
K162931	Ingenia 1.5T CX and Ingenia 3.0T CX R5.3	Philips Medical Systems Nederland B.V.	2017	1
K102344	Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR Systems	Philips Medical Systems Nederland B.V.	2010	1
K190461	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems	Philips Medical Systems Nederland B.V.	2019	0
K103483	Ingenuity TF Pet/MR	Philips Healthcare (Cleveland)	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2026	Class II	Z-3232-2026	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.
May 3, 2024	Class II	Z-1855-2024	Under Investigation by firm	The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Nov 17, 2023	Class I	Z-0505-2024	Component design/selection	Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium…
Oct 23, 2023	Class II	Z-0393-2024	Under Investigation by firm	Potential component failure in the Gradient Coil could product smoke and/or fire.
Oct 23, 2023	Class II	Z-0389-2024	Under Investigation by firm	Potential component failure in the Gradient Coil could product smoke and/or fire.
Oct 23, 2023	Class II	Z-0390-2024	Under Investigation by firm	Potential component failure in the Gradient Coil could product smoke and/or fire.
Oct 23, 2023	Class II	Z-0392-2024	Under Investigation by firm	Potential component failure in the Gradient Coil could product smoke and/or fire.
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.
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.
Aug 13, 2008	Not classified	Z-0971-2009	Process design	Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto…

The 5 latest of 10 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.

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

What does this lineage say?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
6 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K110151 (Philips Health Care, 2011) has gone furthest, with 34 descendants of its own.
5 other devices also cite its predicate K043147.

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. 2007, 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 ACIREVA, INTERA and PANORAMA LOT Release 2.5-series 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, Intera and Panorama 1.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/K063559 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063559: Achieva, Intera and Panorama 1.0T, Release 2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063559

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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