510(k) Report

510(k) · Cleared

Cleared

XRT-7.0

K964583510(k) TraditionalCleared Jan 17, 199763-day reviewClass II21 CFR 892.1750

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

Elscint, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jan 17, 1997 as substantially equivalent to K945512 (Elscint, Inc., 1995) after a 63-day review. Its family tree reaches back 1 generation to 1995.

Decided
Jan 17, 1997
Review
63 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K945512 (1995). No later device cites it as a predicate yet.

K945512 · HRSW Option for CT Twin Flash · Elscint, Inc. · 199519961998
K945512 · HRSW Option for CT Twin Flash · Elscint, Inc. · 19950
  1. Root · 1 generation backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
  2. This deviceK964583 XRT-7.0Elscint, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945512HRSW Option for CT Twin FlashElscint, Inc.1995—
0 (this device)K964583XRT-7.0Elscint, Inc.1997—
FIG. 1 — Lineage of K964583, 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 JAK? 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 JAK device

  1. #1 K230223 iCAC Devicescore 23.5 · 12 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? (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
*K945512HRSW Option for CT Twin Flash
Summary page 1
…sh. The option adds an X- ray tube with 7.0 MHU anode heat capacity to the options list. . Predicate Device CT-Twin flash submitted in “HRSW Option for CT-Twin Flash”, K945512. . Safety The safety of the device is equivalent to the safety of the predicate device, CT Twin flash. The 7.0 MHU tube option…
Elscint, Inc.1995—

Also cleared against K945512: 3 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?

  • Its one ancestor has no recall.
  • 3 other devices also cite its predicate K945512.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

Also cleared against K945512

3 other devices cite the same predicate.

  • K982060Volumax CT Imaging SystemElscint, Inc. · 1998
  • K974344CT ScopeElscint, Inc. · 1998
  • K970980Cardiac Scoring for CT ScannersElscint, 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 JAK

The JAK category page

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  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K964583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964583: XRT-7.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964583

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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