510(k) · Cleared
ClearedMedrad Phased Array 1.5T Shoulder Imaging Surface Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 29, 1996 as substantially equivalent to K892235 (General Electric Co., 1989) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1989. 6 later devices descend from it.
- Decided
- May 29, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892235 (1989). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK892235 GE Shoulder Surface Coil, Cat. #M1085ANGeneral Electric Co. · 1989
- This deviceK960901 Medrad Phased Array 1.5T Shoulder Imaging Surface CoilMedrad, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK984257 Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK023596 Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK093689 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010
- Descendant · 3 generations on · 0 of its ownK052827 Modification to Medrad 8-Receiver Phased Array Neurovascular Coil…Medrad, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK984159 Medrad Quadrature CTL Array CoilMedrad, Inc. · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984257Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999 · cites it directly3descendants
- K023596Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002 · 2 generations on2descendants
- K0936891.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010 · 3 generations on0descendants
- K052827Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for SiemensMedrad, Inc. · 2005 · 3 generations on0descendants
- K984159Medrad Quadrature CTL Array CoilMedrad, Inc. · 1999 · cites it directly0descendants
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) | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface Coil | Medrad, Inc. | 1996 | — |
| +1 | K984257 | Medrad Phased Array Neurovascular Coil | Medrad, Inc. | 1999 | — |
| +2 | K023596 | Medrad 8-Receiver Phased Array Neurovascular Coil | Medrad, Inc. | 2002 | — |
| +3 | K093689 | 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans | Mr Medical Solutions, LLC | 2010 | — |
| +3 | K052827 | Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens | Medrad, Inc. | 2005 | — |
| +1 | K984159 | Medrad Quadrature CTL Array Coil | Medrad, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K892235 | GE Shoulder Surface Coil, Cat. #M1085ANSummary page 1…ry[21 CFR 892.1000} COMMON/USUAL NAME: MRI Surface Coil PROPRIETARY NAME: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil PREDICATE DEVICES: GE Shoulder Coil - K892235 GE Phased Array Breast Coil DEVICE DESCRIPTION: The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is a rigid RF receiv… | 1989 |
| * | K923025 | Signa Breast Coil and Array AccessorySummary page 3…BEMenRran TECHNOLOGY FOR PEOPLE. NEGCHC TECHNOLOGICAL CHARACTERISTICS COMPARISON WITH PREDICATE DEVICES: Proposed che T Predlcate Dewce K892235 Predicate Device - K923025 Compatible with GE 1.5T Signa, Super Conductor Scanners - Phased Array Architecture. Compatible with GE 1 5T Signa, Super Condu… | 1992 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of either the right or left shoulder region with a specific size and shape to facilitate…
Read the full statement (238 words)
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of either the right or left shoulder region with a specific size and shape to facilitate placement on the anatomy area of interest. This placement results in a higher Signal To Noise Ratio(SNR) in the region near the surface coil. The greater SNR permits more effective imaging through the use of a smaller FOV and thinner slices.
The intended ROI for imaging includes the antarior and posterior musculoskeletal area of the shoulder. This includes the rotator cuff, humeral head, glenoid, glenoid labrum and glenoid cavity. The region runs superior through the clavicle and acromion and inferior through the infraspinatus. It also extends posterior to the lateral margin.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended for use in physician diagnosis of impingement syndrome, glenoid labrum tendon tears, rotator cuff tears, edema secondary to the aforementioned, retraction of the supraspinatus muscle and trauma of the long head of the biceps tendon.
Patient fitness and suitability for MRI must be cletermined by the individual physician 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/K960901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960901: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960901
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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