510(k) Report

510(k) · Cleared

Cleared

Flow 7000 Peripheral Vascular Coil

K982339510(k) TraditionalCleared Sep 4, 199860-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 Sep 4, 1998 as substantially equivalent to K964813 (Medical Advances, Inc., 1997) after a 60-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.

Decided
Sep 4, 1998
Review
60 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K964813 (1997). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant clearedReference device: K964531 · Profile 70000 Quadrature Volume Neck Coil · Us Asia Instruments, Inc. · 1997Reference device: K971246 · Leo 7000 Quadrature Knee Coil · Usa Instruments, Inc. · 1997Reference device: K944469 · General Purpose Flex Coil · Philips Medical Systems (Cleveland), Inc. · 1995Reference device: K972340 · Insight 7000 Phased Array Torso Coil · Usa Instruments, Inc. · 1997Reference device: K980157 · Premier 7000 CTL Spine 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. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants K964813 · 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 · 1 generation backK964813 Model 675GE-64 Peripheral Vascular Coil Consisting of Model…Medical Advances, Inc. · 1997
  2. This deviceK982339 Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc. · 1998
  3. Descendant · cites it directly · 1 of its ownK023247 Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002
  4. Descendant · cites it directly · 0 of its ownK042207 11000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K023247Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002 · cites it directly1descendant
  • K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
FIG. 1 — Lineage of K982339, 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K964813Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity…
Summary page 2
…r Coil Same as Predicate Device Intended Use Imaging of vasculature and tissue extending from the torso to the feet. Peripheral Vascular Coil, Medical Advances Inc. (K964813) Indications for Use Identical to routine MRI imaging Peripheral Vascular Coil, Medical Advances Inc. (K964813) Profile 7000…
Medical Advances, Inc.1997—
†K964531Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc.1997—
†K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc.1997—
†K944469General Purpose Flex CoilPhilips Medical Systems (Cleveland), Inc.1995—
†K972340Insight 7000 Phased Array Torso CoilUsa Instruments, Inc.1997—
†K980157Premier 7000 CTL Spine CoilUsa Instruments, Inc.1998—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023247Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc.20021
K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc.20040

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?

  • Its one ancestor has no recall.
  • Of its descendants, K023247 (Usa Instruments, Inc., 2002) has gone furthest, with 1 descendant of its own.

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 Flow 7000 Phased Array Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the abdominal aorta,peripheral vasculature and soft tissue anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR’s Signa 1.5T scanner. Anatomic Regions: Abdominal Vasculature, Peripheral Vasculature and soft tissue Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa 1.5T system…

Read the full statement (140 words)

The Flow 7000 Phased Array Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the abdominal aorta,peripheral vasculature and soft tissue anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR’s Signa 1.5T scanner.

Anatomic Regions: Abdominal Vasculature, Peripheral Vasculature and soft tissue

Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Signa 1.5T 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.

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

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https://510kreport.com/device/K982339 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982339: Flow 7000 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/K982339

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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