510(k) Report

510(k) · Cleared

Cleared

Insight 7000 Phased Array Torso Coil

K972340510(k) TraditionalCleared Aug 21, 199758-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 21, 1997 as substantially equivalent to K962677 (Elscint Mr, Inc., 1996) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1989.

Decided
Aug 21, 1997
Review
58 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K893619 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestorK893619 · Vista MR 2055 HP System · Philips Medical Systems (Cleveland), Inc. · 1989K960497 · Flexible Phased Array Spine Coil · Philips Medical Systems (Cleveland), Inc. · 19961986198819901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K960497 · Flexible Phased Array Spine Coil · Philips Medical Systems (Cleveland), Inc. · 1996K893619 · Vista MR 2055 HP System · Philips Medical Systems (Cleveland), Inc. · 19890
  1. Root · 2 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
  2. 1 generation backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
  3. This deviceK972340 Insight 7000 Phased Array Torso CoilUsa Instruments, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K893619Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc.1989—
−1K960497Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc.1996—
0 (this device)K972340Insight 7000 Phased Array Torso CoilUsa Instruments, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199610
FIG. 1 — Lineage of K972340, 1989–1997Source: 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
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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
*K962677Esteem 1.5T Mri System
Summary page 2
…Phased Array Torso Coil Same as Predicate Device Intended Use Torso Imaging including abdomen, chest, hips Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677) Indications for Use Identical to routine MRI imaging Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677) Pha…
Elscint Mr, Inc.1996—
*K944469General Purpose Flex Coil
Summary page 2
…, Esteem 1.5T MRI System Coil Material ABS Plastic, Naughahyde and Cordura Plus | Elscint MR (fabric material) (K962677) General Purpose Flex Coil Picker International (K944469) Coil Design Four coil receive-only phased Phased Array Body Coil, Esteem 1.5T MRI System array design Elscint MR (K962677) Decou…
Philips Medical Systems (Cleveland), Inc.1995—
*K960497Flexible Phased Array Spine Coil
Summary page 2
…and stiffness does not allow permit looping Phased Array Body Coil, Esteem 1.5T MRI System Elscint MR (K962677) Flexible Phased Array Spine Coil Picker International (K960497) o WEALTy ot 4 3 #, & vic, o SERVIC, » Lop /: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service S…
Philips Medical Systems (Cleveland), Inc.1996—

Also cleared against K962677: 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 8 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K962677.

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 Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR’s Esteem 1.5T scanner. The indications for use are the same as for standard imaging: The Esteem 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…

Read the full statement (122 words)

The Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR’s Esteem 1.5T scanner.

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

The Esteem 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.

Also cleared against K962677

1 other device cites the same predicate.

  • K972826Esteem 1.5T Mri SystemElscint Mr, Inc. · 1997

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

  • K262813InkSpace Imaging Small Body Array (SBA12PH15x)Inkspace Imaging, Inc. · 2026
  • K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS…Philips Medical Systems Nederland B.V. · 2026
  • K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS…Philips Medical Systems Nederland B.V. · 2026
  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K972340 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972340: Insight 7000 Phased Array Torso Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972340

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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