510(k) Report

510(k) · Cleared

Recalled · 2008

Hispeed NX/I CT Scanner System

K991716510(k) TraditionalCleared Jun 18, 199929-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

Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 18, 1999 as substantially equivalent to K980169 (General Electric Co., 1998) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1994. 31 later devices descend from it. It has been recalled 2 times.

Decided
Jun 18, 1999
Review
29 days
Class
Class II
Product code
JAK
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K940606 (1994). 3 ancestors in all. 31 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors2004: 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 clearedK940606 · Hispeed Advantage II · GE Medical Systems · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 4 descendants7 generations forward: 4 descendants8 generations forward: 3 descendants9 generations forward: 4 descendants10 generations forward: 3 descendants11 generations forward: 1 descendant K940606 · Hispeed Advantage II · GE Medical Systems · 19940+5+10
  1. Root · 1 generation backK940606 Hispeed Advantage IIGE Medical Systems · 1994
  2. This deviceK991716 Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc. · 1999
  3. Descendant · cites it directly · 30 of its ownK042328 Somatom SpiritSiemens Medical Systems, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 29 of its ownK140912 Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · Recalled
  5. Descendant · 3 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  6. Descendant · 4 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
  7. Descendant · 4 generations on · 21 of its ownK162302 Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2004: 12014: 12015: 12016: 32017: 32018: 22019: 32020: 22021: 22022: 12023: 32024: 32025: 42026: 2
2004high 4 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 31 · See all
  • K042328Somatom SpiritSiemens Medical Systems, Inc. · 2004 · cites it directly30descendants
  • K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on29descendants
  • K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 3 generations on27descendants
  • K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 4 generations on24descendants
  • K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · 4 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940606Hispeed Advantage IIGE Medical Systems1994—
0 (this device)K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc.1999—
+1K042328Somatom SpiritSiemens Medical Systems, Inc.20042
+2K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc.20142
+3K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.201516
+4K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.20164
+4K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.20161

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201410
201510
201630
201730
201820
201930
202020
202120
202210
202330
202430
202540
202620
FIG. 1 — Lineage of K991716, 1994–2026Source: 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? (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
*K980169Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems
Summary page 1
…ociated accessories. Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169) Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an in…
General Electric Co.19982
*K980176Hispeed QX/I CT Scanner System
Summary page 2
…dy CT scanner utilizing a solid state detector and an intuitive Operator Console with similar features to the HiSpeed LX/i, FX/i and DX/i (K980169), the LightSpeed QX/i (K980176) and options of the HiSpeed CT/i (K940606). Options: SmartView (K973168) and SmartScore (K982004) software options will be avail…
General Electric Co.1998—
*K940606Hispeed Advantage II
Summary page 2
…ctor and an intuitive Operator Console with similar features to the HiSpeed LX/i, FX/i and DX/i (K980169), the LightSpeed QX/i (K980176) and options of the HiSpeed CT/i (K940606). Options: SmartView (K973168) and SmartScore (K982004) software options will be available on HiSpeed LX/i, FX/i and DX/i and Hi…
GE Medical Systems1994—

Also cleared against K980169: 2 other devices →

What descends from it? (31)

See all 31

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042328Somatom SpiritSiemens Medical Systems, Inc.200430

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K042328 (Siemens Medical Systems, Inc., 2004) has gone furthest, with 30 descendants of its own.
  • 2 other devices also cite its predicate K980169.

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 NX/i CT system and HiSpeed options are intended 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.

Also cleared against K980169

2 other devices cite the same predicate.

  • K012106Accuimage Smartgate UpgradeAccuimage Diagnostics Corp. · 2001
  • K993645CT/E Computed Tomography Scannner SystemGe Medical Systems, Inc. · 19992 recalls

More from Ge Medical Systems, Inc.

66 FDA decisions under this applicant name. See the company

  • P870025/S011Corometrics Model 146 Fetal Acoustic Stimulator, 0146Ge Medical Systems, Inc. · 2012
  • P870025/S010Fetal Acoustic StimulatorGe Medical Systems, Inc. · 2011
  • P870025/S009Fetal Acoustic Stimulator (Fast)Ge Medical Systems, Inc. · 2010
  • K091673GE Lightspeed Act FP16Ge Medical Systems, Inc. · 20091 recall
  • K082104GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT SystemGe Medical Systems, Inc. · 20081 recall

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • 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/K991716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991716: Hispeed NX/I CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991716

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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