510(k) · Cleared
ClearedPhased Array Shoulder Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 22, 1996 as substantially equivalent to K945778 (Medical Advances, Inc., 1995) after an 88-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Nov 22, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945778 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945778 Phased Array Shoulder Coil, Quadrature Shoulder CoilMedical Advances, Inc. · 1995
- This deviceK963356 Phased Array Shoulder CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- Descendant · cites it directly · 1 of its ownK083578 Noras CPC Multifunctional CoilNoras Mri Products GmbH · 2009
- Descendant · 2 generations on · 0 of its ownK140252 16 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945778 | Phased Array Shoulder Coil, Quadrature Shoulder Coil | Medical Advances, Inc. | 1995 | — |
| 0 (this device) | K963356 | Phased Array Shoulder Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| +1 | K083578 | Noras CPC Multifunctional Coil | Noras Mri Products GmbH | 2009 | — |
| +2 | K140252 | 16 CH Multipurpose Coil Variety | Noras Rontgen-Und Medizintechnik GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 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 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
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 | Decided |
|---|---|---|---|
| * | K945778 | Phased Array Shoulder Coil, Quadrature Shoulder CoilSummary page 2…ompiled to demonstrate the Shoulder Coil’s substantial equivalence to this device. Parameter Phased Array Shoulder Coil Predicate Device MAI Phased Array Shoulder Coil (K945778) [ Compatible MRI Systems Picker International 1.5 T GE15T Signa with Phased EDGE Array Hardware Option Mode of Operation Same Re… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083578 | Noras CPC Multifunctional Coil | 2009 | 1 |
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 MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 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 Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system. The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted…
Read the full statement (124 words)
The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system.
The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the dete;mination of a diagnosis.
The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Shoulder and other related joint structures
Nuclei Excited: Hydrogen
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/K963356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963356: Phased Array Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963356
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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