510(k) · Cleared
ClearedMark 5000 Phased Array 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 Nov 16, 1998 as substantially equivalent to K945778 (Medical Advances, Inc., 1995) and 4 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1989. 7 later devices descend from it.
- Decided
- Nov 16, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K893619 (1989). 8 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 1 generation backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- This deviceK983143 Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
- Descendant · 3 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
- Descendant · 4 generations on · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
- Descendant · 5 generations on · 0 of its ownK113280 Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002 · cites it directly5descendants
- K033753Pelvic Array CoilUsa Instruments, Inc. · 2003 · 2 generations on4descendants
- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 3 generations on2descendants
- K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · 4 generations on1descendant
- K113280Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −1 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K983143 | Mark 5000 Phased Array Shoulder Coil | Usa Instruments, Inc. | 1998 | — |
| +1 | K013854 | Mark 5000 Quadrature Shoulder Coil | Usa Instruments, Inc. | 2002 | — |
| +2 | K033753 | Pelvic Array Coil | Usa Instruments, Inc. | 2003 | — |
| +3 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
| +4 | K083434 | TT1 General Purpose Coil | Tursiop Technologies, LLC | 2008 | — |
| +5 | K113280 | Carotid Coil GE 1.5T | Tursiop Technologies, LLC | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 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? (5)
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…~ Marks000 S e .. Parameter = . Phased Array Shoulder Coil - ii Predicate o Intended Use Shoulder imaging applications Phased Array Shoulder Coil Medical Advances Inc. (K945778) Indications for Use | Identical to routine MRI imaging Phased Array Shoulder Coil Medical Advances Inc. (K945778) Coil Enclosure… | 1995 |
| * | K960497 | Flexible Phased Array Spine CoilSummary page 2…outine MRI imaging Phased Array Shoulder Coil Medical Advances Inc. (K945778) Coil Enclosure Vinyl Fabric Flexible Phased Array Spine Coil Material Picker International (K960497) ABS/PVC plastic alloy Phased Array CTL Spine Coil Polyurethane Plastic USA Instruments, Inc. (K980157) Coil Design Two channel r… | 1996 |
| * | K980157 | Premier 7000 CTL Spine CoilSummary page 2…ic Flexible Phased Array Spine Coil Material Picker International (K960497) ABS/PVC plastic alloy Phased Array CTL Spine Coil Polyurethane Plastic USA Instruments, Inc. (K980157) Coil Design Two channel receive-only phased array coil | Flexible Phased Array Spine Coil Picker International (K960497) Decoupl… | 1998 |
| * | K945827 | OutlookSummary page 2…nd circuitry are enclosed in a non-conductive housing. Flexible Phased Array Spine Coil Picker International (K960497) Same as other Outlook Coils Picker International (K945827) Radio Frequency Absorption Coil is a receive only coil and does not transmit RF power; power deposition during imaging is limi… | 1995 |
| * | K964531 | Profile 70000 Quadrature Volume Neck CoilSummary page 2…is a receive only coil and does not transmit RF power; power deposition during imaging is limited by SAR algorithm Profile 7000 Volume Neck Coil USA Instruments, Inc. (K964531) Algorithm on Outlook system (K945827) Formation of Resonant Loop Decoupling isolates the coil elements from RF fields during R… | 1997 |
What descends from it? (7)
2 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K013854 (Usa Instruments, Inc., 2002) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K945778.
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 Phased Array 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 Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International. Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen The indications for use are the same as for…
Read the full statement (147 words)
The Mark 5000 Phased Array 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 Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International.
Anatomic Regions: Shoulder and surrounding regions.
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Picker Outlook 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/K983143 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983143: Mark 5000 Phased Array Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983143
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