510(k) Report

510(k) · Cleared

Recalled · 2008

CT Prospeed Family

K944013510(k) TraditionalCleared Feb 7, 1995175-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 · JAK System, X-Ray, Tomography, Computed

Cleared on Feb 7, 1995 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.

Decided
Feb 7, 1995
Review
175 days
Class
Class II
Product code
JAK
Recalls
2
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1995200020052010201520202025
  1. This deviceK944013 CT Prospeed FamilyGE Medical Systems · 1995
  2. Descendant · cites it directly · 0 of its ownK963896 Mobile CT Prospeed FamilyGE Medical Systems · 1996
  3. Descendant · cites it directly · 0 of its ownK961055 CT Prospeed CT/IGE Medical Systems · 1996

Most influential descendants

Showing 2 of 2 · See all
  • K963896Mobile CT Prospeed FamilyGE Medical Systems · 1996 · cites it directly0descendants
  • K961055CT Prospeed CT/IGE Medical Systems · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944013CT Prospeed FamilyGE Medical Systems1995—
+1K963896Mobile CT Prospeed FamilyGE Medical Systems1996—
+1K961055CT Prospeed CT/IGE Medical Systems1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
FIG. 1 — Lineage of K944013, 1995–1996Source: 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K963896Mobile CT Prospeed FamilyGE Medical Systems19960
K961055CT Prospeed CT/IGE Medical Systems19960

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, K963896 (GE Medical Systems, 1996) has gone furthest, with 0 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—

More from GE Medical Systems

170 FDA decisions under this applicant name. See the company

  • K253808AIR Recon DLGE Medical Systems · 2026
  • K220848Venue FitGE Medical Systems · 20221 recall
  • K220851VenueGE Medical Systems · 2022
  • K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 20173 recalls
  • K103411Ideal IQ Software OptionGE Medical Systems · 2011

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/K944013 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944013: CT Prospeed Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944013

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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