510(k) Report

510(k) · Cleared

Cleared

Hispeed Advantage II

K940606510(k) TraditionalCleared Aug 23, 1994194-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

GE Medical Systems · JAK System, X-Ray, Tomography, Computed

Cleared on Aug 23, 1994 after a 194-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 300 later devices descend from it.

Decided
Aug 23, 1994
Review
194 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
0

300 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 3 descendants cleared1999: 1 descendant cleared2001: 2 descendants cleared1998: 1 descendant cleared2016: 9 descendants cleared2004: 8 descendants cleared2014: 10 descendants cleared2008: 7 descendants cleared2003: 3 descendants cleared2009: 4 descendants cleared2015: 4 descendants cleared2017: 15 descendants cleared2011: 4 descendants cleared2007: 3 descendants cleared2005: 3 descendants cleared2006: 3 descendants cleared2018: 16 descendants cleared2019: 12 descendants cleared2013: 6 descendants cleared2010: 2 descendants cleared2012: 6 descendants cleared2020: 24 descendants cleared2024: 22 descendants cleared2023: 22 descendants cleared2025: 38 descendants cleared2022: 23 descendants cleared2021: 21 descendants cleared2026: 27 descendants cleared1990200020102020
  1. This deviceK940606 Hispeed Advantage IIGE Medical Systems · 1994
  2. Descendant · cites it directly · 265 of its ownK964747 Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc. · 1997
  3. Descendant · 2 generations on · 264 of its ownK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
  4. Descendant · 3 generations on · 263 of its ownK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
  5. Descendant · 4 generations on · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
  6. Descendant · 4 generations on · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled

Showing 5 of 300 descendants. See all descendants

Descendants cleared per year

1996: 11997: 31998: 11999: 12001: 22003: 32004: 82005: 32006: 32007: 32008: 72009: 42010: 22011: 42012: 62013: 62014: 102015: 42016: 92017: 152018: 162019: 122020: 242021: 212022: 232023: 222024: 222025: 382026: 27
1996high 38 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 300 · See all
  • K964747Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc. · 1997 · cites it directly265descendants
  • K982060Volumax CT Imaging SystemElscint, Inc. · 1998 · 2 generations on264descendants
  • K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · 3 generations on263descendants
  • K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · 4 generations on214descendants
  • K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · 4 generations on147descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940606Hispeed Advantage IIGE Medical Systems1994—
+1K964747Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc.1997—
+2K982060Volumax CT Imaging SystemElscint, Inc.1998—
+3K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200161
+4K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc.2003131
+4K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199730
199810
199910
200120
200330
200480
200530
200630
200730
200870
200940
201020
201140
201260
201360
2014100
201540
201690
2017150
2018160
2019120
2020240
2021210
2022230
2023220
2024220
2025380
2026270
FIG. 1 — Lineage of K940606, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (300)

See all 300

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

NumberDeviceApplicantDecidedDescendants
K964747Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc.1997265
K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc.199931
K964746Hispeed CT/I with Performix Tube and Warp Scan OptionGE Medical Systems19973
K973168Smartview Options for Hispeed CT/IGE Medical Systems19971
K961055CT Prospeed CT/IGE Medical Systems19960

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?

  • Of its descendants, K964747 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 265 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—

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https://510kreport.com/device/K940606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940606: Hispeed Advantage II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940606

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026