510(k) · Cleared

Cleared

dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

K254190510(k) SpecialCleared Jan 14, 202622-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. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jan 14, 2026 as substantially equivalent to K123492 (Philips Medical Systems, 2012) after a 22-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 14, 2026
Review: 22 days
Class: Class II
Product code: MOS
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 backK123492 DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)Philips Medical Systems · 2012
This deviceK254190 dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck…Philips Medical Systems Nederland B.V. · 2026

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	K123492	DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)	Philips Medical Systems	2012	—
0 (this device)	K254190	dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS…	Philips Medical Systems Nederland B.V.	2026	—

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 K254190, 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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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
*	K123492	DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L) Summary page 5 …1.5T, dS Head 3.0T, dS. Head-Neck 1.5T, dS Head-Neck 3.0T 510(k) Clearance: K123492 Manufacturer: Philips Medical Systems Nederland B.V. Classification Name:…	Philips Medical Systems	2012	—
†	K213735	dS Sentinelle Breast 16ch 1.5T Coil	Invivo Corporation (Business Trade Name: Philips)	2022	—
†	K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…	Invivo Corporation	2021	—

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 23 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
8 of the 9 ancestors have a recall of any class; 4 have a Class I recall.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

What is it indicated for?

The Philips Neurovascular MR Coil is intended to be used in conjunction with a Philips 1.5T or 3T Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K254190 · printed Nov 4, 2026

Cite this page

510(k) Report. “K254190: dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254190

Report an extraction error

Are you the manufacturer?

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