510(k) · Cleared
Cleared1.5T Mrgfus Pelvic Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insightec-Txsonics, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 5, 2007 as substantially equivalent to K033753 (Usa Instruments, Inc., 2003) after a 51-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Sep 5, 2007
- Review
- 51 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K893619 (1989). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 4 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- 3 generations backK983143 Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc. · 1998
- 2 generations backK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
- 1 generation backK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
- This deviceK071966 1.5T Mrgfus Pelvic CoilInsightec-Txsonics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −4 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −3 | K983143 | Mark 5000 Phased Array Shoulder Coil | Usa Instruments, Inc. | 1998 | — |
| −2 | K013854 | Mark 5000 Quadrature Shoulder Coil | Usa Instruments, Inc. | 2002 | — |
| −1 | K033753 | Pelvic Array Coil | Usa Instruments, Inc. | 2003 | — |
| 0 (this device) | 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 |
| 2000 | 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 |
|---|---|---|---|
| * | K033753 | Pelvic Array CoilSummary page 2…5-3 5.9 Regulation Number: CFR 892. 1000 5.10Panel: Radiology 5.11 Predicate Device: Pelvic Array Coil (USA Instruments, Inc.), K033753. 5.12Performance Standards: IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, includin… | 2003 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K033753.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems.
The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071966: 1.5T Mrgfus Pelvic Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071966
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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