510(k) Report

510(k) · Cleared

Cleared

2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)

K972592510(k) TraditionalCleared Sep 15, 199766-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

Elscint, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Sep 15, 1997 as substantially equivalent to K945791 (Elscint, Inc., 1995) and 3 other predicates after a 66-day review. Its family tree reaches back 2 generations to 1995.

Decided
Sep 15, 1997
Review
66 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K954039 (1995). 4 ancestors in all, the oldest K944331 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK954039 · Gyrex Privilege · Elscint, Inc. · 1995K962618 · Gyrex V-EP · Elscint, Inc. · 199619961998
Other ancestors, by generation 1 generation back: 2 other ancestors K962618 · Gyrex V-EP · Elscint, Inc. · 1996K954039 · Gyrex Privilege · Elscint, Inc. · 19950
  1. Root · 2 generations backK954039 Gyrex PrivilegeElscint, Inc. · 1995
  2. 1 generation backK962618 Gyrex V-EPElscint, Inc. · 1996
  3. This deviceK972592 2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP…Elscint, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954039Gyrex PrivilegeElscint, Inc.1995—
−1K962618Gyrex V-EPElscint, Inc.1996—
0 (this device)K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K972592, 1995–1997Source: 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? (4)

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
*K945791Gyres 2T Prestige
Summary page 1
…y for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems. 3. Predicate Devices: The predicate devices are the 2T Prestige (k945791), Privilege (k954039), and Gyrex V-EP (k962618) systems with their shoulder coils, and the General Purspose Flex Coil (k944331).…
Elscint, Inc.1995—
*K954039Gyrex Privilege
Summary page 1
…el because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems. 3. Predicate Devices: The predicate devices are the 2T Prestige (k945791), Privilege (k954039), and Gyrex V-EP (k962618) systems with their shoulder coils, and the General Purspose Flex Coil (k944331). 4. Safety ¢ The MRI…
Elscint, Inc.1995—
*K962618Gyrex V-EP
Summary page 1
…evice was designed only for 0.5T, 1.0T and 1.5T systems. 3. Predicate Devices: The predicate devices are the 2T Prestige (k945791), Privilege (k954039), and Gyrex V-EP (k962618) systems with their shoulder coils, and the General Purspose Flex Coil (k944331). 4. Safety ¢ The MRI safety parameters, SAR, d…
Elscint, Inc.1996—
*K944331Model 528GE Series
Summary page 1
…le coil to image the elbow, hand. ankle, foot. and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (k944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was desig…
Medical Advances, Inc.1995—

Also cleared against K945791: 4 other devices →

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 2 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
  • None of the 4 ancestors has a recall.
  • 4 other devices also cite its predicate K945791.

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?

Magnetic Resonance Imaging of small extremity joints.

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 K945791

4 other devices cite the same predicate.

  • K980306Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EPElscint, Inc. · 1998
  • K974614Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102Elscint, Inc. · 1998
  • K965044Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102Elscint, Inc. · 1997
  • K970005Gyrex 2T-PrestigeElscint, Inc. · 1997

More from Elscint, Inc.

97 FDA decisions under this applicant name. See the company

  • K983313Advanced Automatic Detector Selection Option for GloryElscint, Inc. · 1998
  • K982060Volumax CT Imaging SystemElscint, Inc. · 1998
  • K974344CT ScopeElscint, Inc. · 1998
  • K980306Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EPElscint, Inc. · 1998
  • K974614Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102Elscint, Inc. · 1998

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/K972592 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972592: 2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972592

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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