510(k) · Cleared

Cleared

3D APT

K172920510(k) AbbreviatedCleared Jan 22, 2018119-day reviewClass II21 CFR 892.1000

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 Jan 22, 2018 as substantially equivalent to K163116 (Philips Medical Systems Nederland B.V., 2017) after a 119-day review. Its family tree reaches back 6 generations to 2003. 4 of the 10 devices in its family, counting itself, have a Class I recall.

Decided: Jan 22, 2018
Review: 119 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K031815 (2003). 9 ancestors in all, the oldest K001796 (2000). No later device cites it as a predicate yet. 4 of the 10 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
5 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
4 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
3 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
2 generations backK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · Recalled
1 generation backK163116 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · Recalled
This deviceK172920 3D APTPhilips Medical Systems Nederland B.V. · 2018

Class I recalls in this family

K063559 Achieva, Intera and Panorama 1.0T, Release 2.53 generations back · 2007
K043147 Achieva Family3 generations back · 2005
K052078 Achieva, Intera and Panorama 1.0 Release 2-Series4 generations back · 2005
K041602 Panorama 1.0T4 generations back · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K031815	Intera-Sensation Family	Philips Medical Systems	2003	3
−5	K041602	Panorama 1.0T	Philips Medical Systems North America, Inc.	2004	Class I
−4	K052078	Achieva, Intera and Panorama 1.0 Release 2-Series	Philips Medical Systems Nederland B.V.	2005	Class I
−3	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
−1	K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Philips Medical Systems Nederland B.V.	2017	7
0 (this device)	K172920	3D APT	Philips Medical Systems Nederland B.V.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2005	1	1

FIG. 1 — Lineage of K172920, 2003–2018Source: 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
*	K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Summary page 5 …Philips Medical Systems Nederland B.V. 510(k) Clearance: K163116, January 6, 2017 Classification Regulation: 21CFR 892.1000…	Philips Medical Systems Nederland B.V.	2017	7

Also cleared against K163116: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
9 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
3 other devices also cite its predicate K163116.

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. 2018, 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?

Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172920 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172920: 3D APT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172920

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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