510(k) · Cleared

Recalled · Class II · 2018

Intera I/T

K013344510(k) TraditionalCleared Dec 11, 200163-day reviewClass II21 CFR 892.1000Recalls 2

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

Philips Medical Systems North America Co. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Dec 11, 2001 as substantially equivalent to K001796 (Philips Medical Systems North America, Inc., 2000) after a 63-day review. Its family tree reaches back 1 generation to 2000. 1 of the 56 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it. It has been recalled 2 times.

Decided: Dec 11, 2001
Review: 63 days
Class: Class II
Product code: LNH
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K001796 (2000). 54 later devices descend from it, 1 citing it directly. 1 of the 56 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK001796 Gyroscan Intera (R7.5)Philips Medical Systems North America, Inc. · 2000 · Recalled
This deviceK013344 Intera I/TPhilips Medical Systems North America Co. · 2001
Descendant · cites it directly · 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
Descendant · 3 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 · 4 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 · 5 generations on · 13 of its ownK183063 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · Recalled

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2007high 9 (2018) · low 0 (2008)2026

Class I recalls in this family

K063559 Achieva, Intera and Panorama 1.0T, Release 2.5cites it directly · 2007

Most influential descendants

Showing 5 of 54 · See all

K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · cites it directly53descendants
K110151Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · 2 generations on34descendants
K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · 3 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 · 4 generations on15descendants
K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · 5 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001796	Gyroscan Intera (R7.5)	Philips Medical Systems North America, Inc.	2000	4
0 (this device)	K013344	Intera I/T	Philips Medical Systems North America Co.	2001	—
+1	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
+3	K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Philips Medical Systems Nederland B.V.	2017	7
+4	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
+5	K183063	Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems	Philips Medical Systems Nederland B.V.	2019	25

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	1
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 K013344, 2000–2026Source: 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.

1 device in this family has 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
*	K001796	Gyroscan Intera (R7.5) Summary page 1 …fety standards and/or draft standards are used. Common/Usual Name : INTERA I/T. Predicate Device(s). The Philips cleared MRDD Philips INTERA 1.5T system with FDA ref. K001796. Intended Use. INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device extended with optional hardware extensions…	Philips Medical Systems North America, Inc.	2000	4

Also cleared against K001796: 2 other devices →

What descends from it? (54)

See all 54

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063559	Achieva, Intera and Panorama 1.0T, Release 2.5 Class I	Philips Medical Systems	2007	53

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 21, 2018	Class II	Z-0885-2019	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.
Jul 6, 2015	Class II	Z-1024-2016	Device Design	Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables…

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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K063559 (Philips Medical Systems, 2007) has gone furthest, with 53 descendants of its own.
2 other devices also cite its predicate K001796.

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?

INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device being extended with optional hardware extensions to aid in the performance of interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time 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/K013344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013344: Intera I/T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013344

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026