510(k) Report

510(k) · Cleared

Cleared

Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102

K965044510(k) TraditionalCleared Jun 16, 1997185-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. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 16, 1997 as substantially equivalent to K945791 (Elscint, Inc., 1995) and 1 other predicate after a 185-day review. Its family tree reaches back 1 generation to 1995.

Decided
Jun 16, 1997
Review
185 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K945791 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK945791 · Gyres 2T Prestige · Elscint, Inc. · 199519961998
Other ancestors, by generation 1 generation back: 1 other ancestor K945791 · Gyres 2T Prestige · Elscint, Inc. · 19950
  1. Root · 1 generation backK945791 Gyres 2T PrestigeElscint, Inc. · 1995
  2. This deviceK965044 Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model…Elscint, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945791Gyres 2T PrestigeElscint, Inc.1995—
0 (this device)K965044Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO.…Elscint, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K965044, 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 LNH? 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 LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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? (2)

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
…gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques. 3. Predicate Devices: Gyrex 2T Prestige system (k945791), Gyrex Privilege system (k954039). 4. Safety e The MRI safety parameters, SAR, dB/dt, B, and acoustic noise, are unchanged by…
Elscint, Inc.1995—
*K954039Gyrex Privilege
Summary page 1
…RF excitation, thereby allowing faster imaging than standard gradient echo techniques. 3. Predicate Devices: Gyrex 2T Prestige system (k945791), Gyrex Privilege system (k954039). 4. Safety e The MRI safety parameters, SAR, dB/dt, B, and acoustic noise, are unchanged by the current modification. e Electr…
Elscint, 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?

  • None of the 2 ancestors has a recall.
  • 4 other devices also cite its predicate K945791.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

Whole Body Magnet Resonance Imaging

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
  • K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, 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 LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K965044 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965044: Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965044

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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