510(k) · Cleared

Cleared

Synergy Shoulder Coil

K991765510(k) TraditionalCleared Aug 2, 199970-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 Aug 2, 1999 as substantially equivalent to K980645 (Philips Medical Systems North America, Inc., 1998) after a 70-day review. Its family tree reaches back 2 generations to 1997.

Decided: Aug 2, 1999
Review: 70 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K963990 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK963990 Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 SeriesPhilips Medical Systems, Inc. · 1997
1 generation backK980645 Philips Gyroscan NT Release 6 SeriesPhilips Medical Systems North America, Inc. · 1998
This deviceK991765 Synergy Shoulder CoilPhilips Medical Systems North America, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K963990	Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series	Philips Medical Systems, Inc.	1997	—
−1	K980645	Philips Gyroscan NT Release 6 Series	Philips Medical Systems North America, Inc.	1998	—
0 (this device)	K991765	Synergy Shoulder Coil	Philips Medical Systems North America, Inc.	1999	—

FIG. 1 — Lineage of K991765, 1997–1999Source: 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
*	K980645	Philips Gyroscan NT Release 6 Series Summary page 1 …Philips RF external E1 flexible coil and other current synergy coils as part of the commercially cleared MRDD Philips GYROSCAN NT Release 6 series systems with FDA ref. K980645. Intended use. Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the ma…	Philips Medical Systems North America, Inc.	1998	—

Also cleared against K980645: 3 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?

The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K980645.

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?

Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the main purpose of optimal imaging of the shoulder structure. It is compatible to be used with the Philips GYROSCAN NT systems which are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 31p metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra 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/K991765 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991765: Synergy Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991765

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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