510(k) · Cleared
ClearedShoulder Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 14, 2001 as substantially equivalent to K983143 (Usa Instruments, Inc., 1998) and 1 other predicate after a 51-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 14, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K893619 (1989). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 2 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- 1 generation backK983143 Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc. · 1998
- This deviceK013541 Shoulder CoilUsa Instruments, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −2 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −1 | K983143 | Mark 5000 Phased Array Shoulder Coil | Usa Instruments, Inc. | 1998 | — |
| 0 (this device) | K013541 | Shoulder Coil | Usa Instruments, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K983143 | Mark 5000 Phased Array Shoulder CoilSummary page 2…vice or other 510(k) Cleared Product Intended Use Shoulder imaging applications -Similar to Mark 5000 Phased Array Shoulder Coil manufactured by USA Instruments, Inc. (K983143) - Similar to Phased Array Shoulder Coil manufactured by Medical Advances Inc. (K945778) Indications for Use Identical to routin… | 1998 |
| * | K945778 | Phased Array Shoulder Coil, Quadrature Shoulder CoilSummary page 2…ar to Mark 5000 Phased Array Shoulder Coil manufactured by USA Instruments, Inc. (K983143) - Similar to Phased Array Shoulder Coil manufactured by Medical Advances Inc. (K945778) Indications for Use Identical to routine MRI imaging -Similar to Mark 5000 Phased Array Shoulder Coil manufactured by USA Ins… | 1995 |
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 12 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K983143.
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 Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Shoulder Coil is designed for use with the Rhapsody (1.0 Tesla) MRI scanner manufactured by Siemens Medical Systems, Inc. Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Siemens…
Read the full statement (141 words)
The Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Shoulder Coil is designed for use with the Rhapsody (1.0 Tesla) MRI scanner manufactured by Siemens Medical Systems, Inc.
Anatomic Regions: Shoulder and surrounding regions.
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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 determination of a 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/K013541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013541: 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/K013541
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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