510(k) Report

510(k) · Cleared

Recalled · 2008

Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems

K980169510(k) TraditionalCleared Apr 13, 199887-day reviewClass II21 CFR 892.1750Recalls 2

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

General Electric Co. · JAK System, X-Ray, Tomography, Computed

Cleared on Apr 13, 1998 after an 87-day review. The FDA summary names its predicate without a number. 35 later devices descend from it. It has been recalled 2 times.

Decided
Apr 13, 1998
Review
87 days
Class
Class II
Product code
JAK
Recalls
2
Predicates
0

35 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1999: 2 descendants cleared2004: 1 descendant cleared2002: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2019: 3 descendants cleared2021: 2 descendants cleared2023: 3 descendants cleared2020: 2 descendants cleared2022: 1 descendant cleared2024: 3 descendants cleared2025: 4 descendants cleared2026: 2 descendants clearedReference device: K940606 · Hispeed Advantage II · GE Medical Systems · 19941995200020052010201520202025
  1. This deviceK980169 Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsGeneral Electric Co. · 1998
  2. Descendant · cites it directly · 31 of its ownK991716 Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 30 of its ownK042328 Somatom SpiritSiemens Medical Systems, Inc. · 2004 · Recalled
  4. Descendant · 3 generations on · 29 of its ownK140912 Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · Recalled
  5. Descendant · 4 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  6. Descendant · 5 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

1999: 22001: 12002: 12004: 12014: 12015: 12016: 32017: 32018: 22019: 32020: 22021: 22022: 12023: 32024: 32025: 42026: 2
1999high 4 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 35 · See all
  • K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc. · 1999 · cites it directly31descendants
  • K042328Somatom SpiritSiemens Medical Systems, Inc. · 2004 · 2 generations on30descendants
  • K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on29descendants
  • K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 4 generations on27descendants
  • K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 5 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980169Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsGeneral Electric Co.1998—
+1K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc.19992
+2K042328Somatom SpiritSiemens Medical Systems, Inc.20042
+3K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc.20142
+4K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.201516
+5K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.20164

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200210
200410
201410
201510
201630
201730
201820
201930
202020
202120
202210
202330
202430
202540
202620
FIG. 1 — Lineage of K980169, 1998–2026Source: 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
*—currently marketed head and whole body x-ray computed tomography systems
Named without a submission number
—
†K940606Hispeed Advantage IIGE Medical Systems1994—

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc.199931
K993645CT/E Computed Tomography Scannner SystemGe Medical Systems, Inc.19991
K012106Accuimage Smartgate UpgradeAccuimage Diagnostics Corp.20010

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 1, 2008Not classifiedZ-2224-2009Radiation Control for Health and Safety ActDuring internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the…
Oct 21, 2004Not classifiedZ-0269-05OtherThe patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K991716 (Ge Medical Systems, Inc., 1999) has gone furthest, with 31 descendants of its own.

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—

What is it indicated for?

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems are indicated for head and whole body x-ray computed tomography applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from General Electric Co.

270 FDA decisions under this applicant name. See the company

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  • K073297GE Logiq P6General Electric Co. · 20072 recalls
  • K072952GE EchopacGeneral Electric Co. · 2007

Recent decisions in JAK

The JAK category page

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https://510kreport.com/device/K980169 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980169: Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980169

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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