510(k) · Cleared
ClearedMark 5000 Quadrature Shoulder 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 Feb 6, 2002 as substantially equivalent to K983143 (Usa Instruments, Inc., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 3 generations to 1989. 5 later devices descend from it.
- Decided
- Feb 6, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K893619 (1989). 13 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- 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 deviceK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
- Descendant · 4 generations on · 0 of its ownK113280 Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK071966 1.5T Mrgfus Pelvic CoilInsightec-Txsonics, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K033753Pelvic Array CoilUsa Instruments, Inc. · 2003 · cites it directly4descendants
- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 2 generations on2descendants
- K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · 3 generations on1descendant
- K113280Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011 · 4 generations on0descendants
- K0719661.5T Mrgfus Pelvic CoilInsightec-Txsonics, Inc. · 2007 · 2 generations on0descendants
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) | K013854 | Mark 5000 Quadrature Shoulder Coil | Usa Instruments, Inc. | 2002 | — |
| +1 | K033753 | Pelvic Array Coil | Usa Instruments, Inc. | 2003 | — |
| +2 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
| +3 | K083434 | TT1 General Purpose Coil | Tursiop Technologies, LLC | 2008 | — |
| +4 | K113280 | Carotid Coil GE 1.5T | Tursiop Technologies, LLC | 2011 | — |
| +2 | K071966 | 1.5T Mrgfus Pelvic Coil | Insightec-Txsonics, Inc. | 2007 | — |
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 | 4 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 Coil Our OCR of the scanned summary read K893143, FDA’s number for Latex Exam Gloves (MFG. Guangdong Zhongshan) (Guangzhou Chemicals Import & Export Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mark 5000 Phased Array Shoulder Coil”. | 1998 |
| * | K992650 | Airis, Airis IISummary page 2…5000 Phased Array Shoulder Coil manufactured by USA Instruments Inc. (K893143) -Similar to the Quadrature Shoulder Coil manufactured by Hitachi Medical Systems America (K992650) Indications for Use Identical to routine MRI! imaging ~Similar to the Mark 5000 Phased Array Shoulder Coil manufactured by USA… | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033753 | Pelvic Array Coil | 2003 | 4 |
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 13 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K033753 (Usa Instruments, Inc., 2003) has gone furthest, with 4 descendants of its own.
- 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 Mark 5000 Quadrature Shoulder Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Quadrature Shoulder Coil is designed for use with the Toshiba Opart 0.35Tesla MRI scanner manufactured by Toshiba Medical Systems, Inc. Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen The indications for use are the same…
Read the full statement (147 words)
The Mark 5000 Quadrature Shoulder Coil is a receive-only
quadrature RF coil, used for obtaining diagnostic images of the shoulder and
surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000
Quadrature Shoulder Coil is designed for use with the Toshiba Opart 0.35Tesla
MRI scanner manufactured by Toshiba Medical Systems, Inc.
Anatomic Regions: Shoulder and surrounding regions.
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Toshiba Opart MRI 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/K013854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013854: Mark 5000 Quadrature Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013854
Report an extraction error
Are you the manufacturer?
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