510(k) · Cleared

Recalled · 2009

Intera-Sensation Family

K031815510(k) TraditionalCleared Sep 10, 200390-day reviewClass II21 CFR 892.1000Recalls 3

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 Sep 10, 2003 after a 90-day review. The FDA summary names its predicate without a number. 5 of the 68 devices in its family, counting itself, have a Class I recall. 67 later devices descend from it. It has been recalled 3 times.

Decided: Sep 10, 2003
Review: 90 days
Class: Class II
Product code: LNH
Recalls: 3
Predicates: 0

67 later devices descend from it, 2 citing it directly. 5 of the 68 devices in this family, counting this one, have a Class I recall.

This deviceK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003
Descendant · cites it directly · 65 of its ownK043147 Achieva FamilyPhilips Medical Systems North America Co. · 2005 · Recalled (Class I)
Descendant · cites it directly · 58 of its ownK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
Descendant · 2 generations on · 57 of its ownK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
Descendant · 2 generations on · 53 of its ownK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
Descendant · 2 generations on · 34 of its ownK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · Recalled

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2004high 10 (2018) · low 0 (2006)2026

Class I recalls in this family

K043147 Achieva Familycites it directly · 2005
K041602 Panorama 1.0Tcites it directly · 2004
K063559 Achieva, Intera and Panorama 1.0T, Release 2.52 generations on · 2007
K052078 Achieva, Intera and Panorama 1.0 Release 2-Series2 generations on · 2005

Most influential descendants

Showing 5 of 67 · See all

K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · cites it directly65descendants
K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · cites it directly58descendants
K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 2 generations on57descendants
K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 2 generations on53descendants
K110151Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · 2 generations on34descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031815	Intera-Sensation Family	Philips Medical Systems	2003	—
+1	K043147	Achieva Family	Philips Medical Systems North America Co.	2005	Class I
+1	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
+2	K063559	Achieva, Intera and Panorama 1.0T, Release 2.5	Philips Medical Systems	2007	Class I
+2	K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	2011	20

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	1
2005	3	3
2007	1	1
2008	2	0
2010	2	0
2011	4	0
2012	4	0
2013	1	0
2014	2	0
2015	4	0
2016	3	0
2017	3	0
2018	10	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 K031815, 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.

5 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? (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
*	—	Gyroscan INTERA family release 10-series Named without a submission number			—

What descends from it? (67)

See all 67

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

Number	Device	Applicant	Decided	Descendants
K043147	Achieva Family Class I	Philips Medical Systems North America Co.	2005	65
K041602	Panorama 1.0T Class I	Philips Medical Systems North America, Inc.	2004	58

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2009	Not classified	Z-0794-2011	Nonconforming Material/Component	The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
May 1, 2009	Not classified	Z-0469-2011	Other	Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.
Apr 30, 2007	Not classified	Z-0983-2007	Other	Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

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.

K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 13 Class I recalls
K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K052013Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V. · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Of its descendants, K043147 (Philips Medical Systems North America Co., 2005) has gone furthest, with 65 descendants of its own.

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 indication for use for the INTERA SENSATION Release 1-series remains the same as the previous released predicate device(s), i.e. the capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031815 · printed Nov 3, 2026

Cite this page

510(k) Report. “K031815: Intera-Sensation Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031815

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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