510(k) · Cleared

Cleared

Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64SHC, M42SHC, M21SHC

K982916510(k) TraditionalCleared Oct 29, 199871-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

Medrad, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Oct 29, 1998 as substantially equivalent to K892235 (General Electric Co., 1989) after a 71-day review. Its family tree reaches back 1 generation to 1989.

Decided: Oct 29, 1998
Review: 71 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K892235 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK892235 GE Shoulder Surface Coil, Cat. #M1085ANGeneral Electric Co. · 1989
This deviceK982916 Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64SHC, M42SHC, M21SHCMedrad, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K892235	GE Shoulder Surface Coil, Cat. #M1085AN	General Electric Co.	1989	—
0 (this device)	K982916	Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64SHC, M42SHC, M21SHC	Medrad, Inc.	1998	—

FIG. 1 — Lineage of K982916, 1989–1998Source: 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

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
*	K892235	GE Shoulder Surface Coil, Cat. #M1085AN Summary page 2 …PARISON TO PREDICATE DEVICES: The following table compares the predicate GE Shoulder Coil and the proposed Medrad Shoulder Coil. GE Shoulder Coil Medrad Shoulder Coil (K892235) GE labeling Medrad labeling Medrad was responsible for the design and manufacturing of the predicate device, and will remain re…	General Electric Co.	1989	—

Also cleared against K892235: 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 no recall.
2 other devices also cite its predicate K892235.

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 Medrad Shoulder Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the shoulder anatomy.

The Medrad Shoulder Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.

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/K982916 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982916: Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64SHC, M42SHC, M21SHC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982916

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