510(k) · Cleared

Recalled · Class I · 2026

Achieva 1.5T & Inera 1.5T Family

K052013510(k) TraditionalCleared Aug 2, 20057-day reviewClass II21 CFR 892.1000Recalls 27 (3 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 Nederland B.V. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Aug 2, 2005 as substantially equivalent to K043147 (Philips Medical Systems North America Co., 2005) after a 7-day review. Its family tree reaches back 2 generations to 2003. 2 of the 7 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 27 times, including 3 Class I recalls.

Decided: Aug 2, 2005
Review: 7 days
Class: Class II
Product code: LNH
Recalls: 27 (3 Class I)
Predicates: 1

Its longest line of descent runs back 2 generations to K031815 (2003). 4 later devices descend from it, 2 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
1 generation backK043147 Achieva FamilyPhilips Medical Systems North America Co. · 2005 · Recalled (Class I)
This deviceK052013 Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V. · 2005
Descendant · cites it directly · 2 of its ownK080048 MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc. · 2008 · Recalled
Descendant · 2 generations on · 1 of its ownK103238 1.5T Optima MR430SGe Medical Systems, LLC · 2011 · Recalled
Descendant · cites it directly · 0 of its ownK131896 Supervan 1.5T Magnetic Resonance Imaging SystemSuzhou Anke Medical System Co., Ltd. · 2014
Descendant · 3 generations on · 0 of its ownK123068 Optima MR 430SGe Medical Systems, LLC · 2012 · Recalled

Class I recalls in this family

K043147 Achieva Familydirect predicate · 2005

Most influential descendants

Showing 4 of 4 · See all

K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc. · 2008 · cites it directly2descendants
K1032381.5T Optima MR430SGe Medical Systems, LLC · 2011 · 2 generations on1descendant
K131896Supervan 1.5T Magnetic Resonance Imaging SystemSuzhou Anke Medical System Co., Ltd. · 2014 · cites it directly0descendants
K123068Optima MR 430SGe Medical Systems, LLC · 2012 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K031815	Intera-Sensation Family	Philips Medical Systems	2003	3
−1	K043147	Achieva Family	Philips Medical Systems North America Co.	2005	Class I
0 (this device)	K052013	Achieva 1.5T & Inera 1.5T Family	Philips Medical Systems Nederland B.V.	2005	—
+1	K080048	MSK Extreme MR Scanner, Model AA5000	Oni Medical Systems, Inc.	2008	3
+2	K103238	1.5T Optima MR430S	Ge Medical Systems, LLC	2011	2
+1	K131896	Supervan 1.5T Magnetic Resonance Imaging System	Suzhou Anke Medical System Co., Ltd.	2014	—
+3	K123068	Optima MR 430S	Ge Medical Systems, LLC	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2012	1	0
2014	1	0

FIG. 1 — Lineage of K052013, 2003–2014Source: 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.

2 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
*	K043147	Achieva Family Summary page 1 …e Device(s): The Philips Medical Systems ACHIEVA 1.5T & INTERA 1.5T are the successors of the already cleared (predicate device) ACHIEVA family release 1-series (ref. K043147). Indications for use: The ACHIEVA 1.5T & INTERA 1.5T consists of diagnostic devices that produce cross- sectional images,…	Philips Medical Systems North America Co.	2005	Class I

Also cleared against K043147: 5 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K080048	MSK Extreme MR Scanner, Model AA5000	Oni Medical Systems, Inc.	2008	2
K131896	Supervan 1.5T Magnetic Resonance Imaging System	Suzhou Anke Medical System Co., Ltd.	2014	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2026	Class II	Z-3240-2026	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 21, 2026	Class II	Z-3233-2026	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 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.
Jun 5, 2024	Class I	Z-2165-2024	Device Design	Potential for coils to heat up and harm patients (burn).
Jun 5, 2024	Class I	Z-2163-2024	Device Design	Potential for coils to heat up and harm patients (burn).
Jun 5, 2024	Class I	Z-2164-2024	Device Design	Potential for coils to heat up and harm patients (burn).
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.
Dec 21, 2018	Class II	Z-0889-2019	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-0890-2019	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-0892-2019	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-0894-2019	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-0896-2019	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-0909-2019	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-0887-2019	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-0888-2019	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-0891-2019	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-0895-2019	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-0899-2019	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-0915-2019	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-0908-2019	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-0912-2019	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.
Mar 16, 2018	Class II	Z-1435-2018	Nonconforming Material/Component	Potential risk for helium gas inside the MR examination room during a magnet quench
Mar 16, 2018	Class II	Z-1433-2018	Nonconforming Material/Component	Potential risk for helium gas inside the MR examination room during a magnet quench
Sep 30, 2008	Not classified	Z-2461-2010	Other	The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination…

The 5 latest of 27 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.

K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K080048 (Oni Medical Systems, Inc., 2008) has gone furthest, with 2 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.

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?

ACHIEVA 1.5 & INTERA 1.ST family consists of 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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052013 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052013: Achieva 1.5T & Inera 1.5T Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052013

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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