510(k) · Cleared

Recalled · Class I · 2024

Achieva Family

K043147510(k) TraditionalCleared Feb 15, 200592-day reviewClass II21 CFR 892.1000Recalls 13 (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 North America Co. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 15, 2005 as substantially equivalent to K031815 (Philips Medical Systems, 2003) after a 92-day review. Its family tree reaches back 1 generation to 2003. 4 of the 67 devices in its family, counting itself, have a Class I recall. 65 later devices descend from it. It has been recalled 13 times, including 3 Class I recalls.

Decided: Feb 15, 2005
Review: 92 days
Class: Class II
Product code: LNH
Recalls: 13 (3 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K031815 (2003). 65 later devices descend from it, 6 citing it directly. 4 of the 67 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
This deviceK043147 Achieva FamilyPhilips Medical Systems North America Co. · 2005
Descendant · cites it directly · 57 of its ownK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
Descendant · cites it directly · 53 of its ownK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
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

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2005high 10 (2018) · low 0 (2006)2026

Class I recalls in this family

K063559 Achieva, Intera and Panorama 1.0T, Release 2.5cites it directly · 2007
K052078 Achieva, Intera and Panorama 1.0 Release 2-Seriescites it directly · 2005
K052013 Achieva 1.5T & Inera 1.5T Familycites it directly · 2005

Most influential descendants

Showing 5 of 65 · See all

K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · cites it directly57descendants
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 · 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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031815	Intera-Sensation Family	Philips Medical Systems	2003	3
0 (this device)	K043147	Achieva Family	Philips Medical Systems North America Co.	2005	—
+1	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
+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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	2
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 K043147, 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? (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
*	K031815	Intera-Sensation Family Summary page 1 …Predicate Device(s): The Philips Medical Systems ACHIEVA is the successor of the already cleared (predicate device) INTERA ACHIEVA family release 1-series (ref.K031815). Indications for use: The ACHIEVA family consists of diagnostic devices that produce cross-sectional images, spectrosc…	Philips Medical Systems	2003	3

Also cleared against K031815: 1 other device →

What descends from it? (65)

See all 65

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

Number	Device	Applicant	Decided	Descendants
K052078	Achieva, Intera and Panorama 1.0 Release 2-Series Class I	Philips Medical Systems Nederland B.V.	2005	57
K063559	Achieva, Intera and Panorama 1.0T, Release 2.5 Class I	Philips Medical Systems	2007	53
K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	2011	34
K052013	Achieva 1.5T & Inera 1.5T Family Class I	Philips Medical Systems Nederland B.V.	2005	4
K163661	P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil	Rapid Biomedical GmbH	2018	0
K120748	Speedup Software Option	Esaote, S.p.A.	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
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).
Dec 21, 2018	Class II	Z-0893-2019	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-0905-2019	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-0907-2019	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-0913-2019	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-0914-2019	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-0884-2019	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-0897-2019	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-0927-2019	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-0928-2019	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-0906-2019	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.

The 5 latest of 13 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 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K052013Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K052078 (Philips Medical Systems Nederland B.V., 2005) has gone furthest, with 57 descendants of its own.
1 other device also cites its predicate K031815.

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 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/K043147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043147: Achieva Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043147

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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