510(k) · Cleared

Cleared

Tansmit/Receive Quadrature Body Coil 3.0T

K013894510(k) TraditionalCleared Jan 18, 200256-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 North America, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jan 18, 2002 as substantially equivalent to K001796 (Philips Medical Systems North America, Inc., 2000) after a 56-day review. Its family tree reaches back 1 generation to 2000.

Decided: Jan 18, 2002
Review: 56 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001796 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK001796 Gyroscan Intera (R7.5)Philips Medical Systems North America, Inc. · 2000 · Recalled
This deviceK013894 Tansmit/Receive Quadrature Body Coil 3.0TPhilips Medical Systems North America, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001796	Gyroscan Intera (R7.5)	Philips Medical Systems North America, Inc.	2000	4
0 (this device)	K013894	Tansmit/Receive Quadrature Body Coil 3.0T	Philips Medical Systems North America, Inc.	2002	—

FIG. 1 — Lineage of K013894, 2000–2002Source: 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.

Planning a device in MOS? 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
*	K001796	Gyroscan Intera (R7.5) Summary page 2 …ety and Effectiveness. The safety of the INTERA 3.0T system with the Transmit/Receive Quadrature Body Coil 3.0T remain the same as with the FDA cleared INTERA 1.5T (re. K001796).The Transmit/Receive Quadrature Body Coil 3.0T permits the INTERA 3.0T system to be used as a whole body scanner. It was distrib…	Philips Medical Systems North America, Inc.	2000	4

Also cleared against K001796: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
2 other devices also cite its predicate K001796.

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.

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 indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013894 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013894: Tansmit/Receive Quadrature Body Coil 3.0T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013894

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026