510(k) · Cleared

Cleared

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

K163661510(k) TraditionalCleared Mar 21, 2018449-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

Rapid Biomedical GmbH · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 21, 2018 as substantially equivalent to K043147 (Philips Medical Systems North America Co., 2005) after a 449-day review. Its family tree reaches back 2 generations to 2003. 1 of the 3 devices in its family, counting itself, has a Class I recall.

Decided: Mar 21, 2018
Review: 449 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K031815 (2003). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has 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 deviceK163661 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilRapid Biomedical GmbH · 2018

Class I recalls in this family

K043147 Achieva Familydirect predicate · 2005

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)	K163661	P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil	Rapid Biomedical GmbH	2018	—

FIG. 1 — Lineage of K163661, 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.

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 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

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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 5 …n of the cleared Philips Magnetic Resonance Diagnostic Devices (MRDD) which are described in the submission: Predicate Device Name Clearance Number Date ACHIEVA family K043147 2005-02-15 File: 001_K163661_Suppl001_510(k) Summary.doc Confidential _ Page 2/4 RAPID Traditional 510(k) Premar…	Philips Medical Systems North America Co.	2005	Class I

Also cleared against K043147: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 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.

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 15 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
5 other devices also cite its predicate K043147.

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. 2018, 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 P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

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/K163661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163661: P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163661

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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