510(k) Report

510(k) · Cleared

Cleared

11000 Rapture Phased Array Peripheral Vascular Coil

K042207510(k) TraditionalCleared Aug 26, 200410-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Aug 26, 2004 as substantially equivalent to K982339 (Usa Instruments, Inc., 1998) and 2 other predicates after a 10-day review. Its family tree reaches back 3 generations to 1997.

Decided
Aug 26, 2004
Review
10 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K964813 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorReference device: K031172 · Spirit Iii Totalsense Cardiac Coil · Usa Instruments, Inc. · 2003K964813 · Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64: · Medical Advances, Inc. · 1997K982339 · Flow 7000 Peripheral Vascular Coil · Usa Instruments, Inc. · 1998K023247 · Champion 5000 Peripheral Vascular Coil · Usa Instruments, Inc. · 2002199619982000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K023247 · Champion 5000 Peripheral Vascular Coil · Usa Instruments, Inc. · 2002K982339 · Flow 7000 Peripheral Vascular Coil · Usa Instruments, Inc. · 1998K964813 · Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64: · Medical Advances, Inc. · 19970
  1. Root · 3 generations backK964813 Model 675GE-64 Peripheral Vascular Coil Consisting of Model…Medical Advances, Inc. · 1997
  2. 2 generations backK982339 Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc. · 1998
  3. 1 generation backK023247 Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002
  4. This deviceK042207 11000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K964813Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower…Medical Advances, Inc.1997—
−2K982339Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc.1998—
−1K023247Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc.2002—
0 (this device)K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K042207, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K982339Flow 7000 Peripheral Vascular Coil
Summary page 2
…g of vasculatureand -Similar to the Flow 7000 Peripheral Vascular Coil soft tissue anatomy extending from the manufactured by USA Instruments, Inc. (K982339, torso to the foot region K010730) and Champion 5000 (K023247). Indications for Use: Identical to routi…
Usa Instruments, Inc.1998—
*K010730Modification to Flow 7000 Peripheral Vascular Coil
Summary page 2
…ipheral Vascular Coil soft tissue anatomy extending from the manufactured by USA Instruments, Inc. (K982339, torso to the foot region K010730) and Champion 5000 (K023247). Indications for Use: Identical to routine -Similar to the Flow 7000 Peripheral Vascular Co…
Usa Instruments, Inc.2001—
*K023247Champion 5000 Peripheral Vascular Coil
Summary page 2
…issue anatomy extending from the manufactured by USA Instruments, Inc. (K982339, torso to the foot region K010730) and Champion 5000 (K023247). Indications for Use: Identical to routine -Similar to the Flow 7000 Peripheral Vascular Coil MRI imaging…
Usa Instruments, Inc.2002—
†K031172Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc.2003—

Also cleared against K982339: 1 other device →

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 7 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K982339.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007: 162008: 192009: 102010: 162011: 252012: 152013: 72014: 122015: 62016: 112017: 92018: 102019: 32020: 52021: 42022: 112023: 102024: 102025: 32026 (partial year): 10
2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007: 19 days median2008: 33 days median2009: 43 days median2010: 78 days median2011: 57 days median2012: 49 days median2013: 87 days median2014: 60 days median2015: 58 days median2016: 42 days median2017: 63 days median2018: 30 days median2019: 178 days median2020: 51 days median2021: 41 days median2022: 79 days median2023: 59 days median2024: 39 days median2025: 59 days median2026 (partial year): 45 days median
2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2008: 22010: 12012: 12015: 22019: 82020: 12024: 13
2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007: 42008: 22009: 52010: 132011: 72012: 122013: 102014: 42015: 52016: 72017: 92018: 72019: 82020: 22021: 32022: 52023: 42024: 82025: 2
2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007161904
2008193322
2009104305
20101678113
2011255707
20121549112
2013787010
2014126004
201565825
2016114207
201796309
2018103007
2019317888
202055112
202144103
2022117905
2023105904
20241039138
202535902
202610450—

What is it indicated for?

The Rapture 11000 a phased array peripheral vascular coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from below the knee to the foot region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies.

Indications for use as stated in the FDA summary.

Also cleared against K982339

1 other device cites the same predicate.

  • K023247Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002

More from Usa Instruments, Inc.

64 FDA decisions under this applicant name. See the company

  • K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 20051 recall
  • K0526211.5T 16 Channel Brain-Spine Array CoilUsa Instruments, Inc. · 20051 recall
  • K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
  • K0525853T HD Breast ArrayUsa Instruments, Inc. · 20055 recalls
  • K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005

Recent decisions in MOS

The MOS category page

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  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K042207 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042207: 11000 Rapture Phased Array Peripheral Vascular Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042207

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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