510(k) Report

510(k) · Cleared

Cleared

GE Veo Reconstruction Option

K103489510(k) TraditionalCleared Sep 9, 2011287-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

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

Cleared on Sep 9, 2011 as substantially equivalent to K081105 (GE Healthcare, 2008) after a 287-day review. Its family tree reaches back 5 generations to 2001. 10 later devices descend from it.

Decided
Sep 9, 2011
Review
287 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K013561 (2001). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2019: 2 descendants cleared2020: 2 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK013561 · Lightspeed 4.0 CT Scanner System · GE Medical Systems · 2001 · recalledK030420 · Lightspeed 5.0 Computed Tomography System · GE Medical Systems · 2003 · recalledK040372 · Lightspeed 7.0 CT Scanner System · Ge Medical Systems, LLC · 2004 · recalledK061817 · Lightspeed 7.1 CT Scanner System · Ge Medical Systems, LLC · 2006 · recalledK081105 · GE Lightspeed CT750 HD (Lightspeed 8.0) · GE Healthcare · 2008 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 5 descendants4 generations forward: 3 descendants K081105 · GE Lightspeed CT750 HD (Lightspeed 8.0) · GE Healthcare · 2008 · recalledK061817 · Lightspeed 7.1 CT Scanner System · Ge Medical Systems, LLC · 2006 · recalledK040372 · Lightspeed 7.0 CT Scanner System · Ge Medical Systems, LLC · 2004 · recalledK030420 · Lightspeed 5.0 Computed Tomography System · GE Medical Systems · 2003 · recalledK013561 · Lightspeed 4.0 CT Scanner System · GE Medical Systems · 2001 · recalled−50
  1. Root · 5 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
  2. 4 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
  3. 3 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
  4. 2 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
  5. 1 generation backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
  6. This deviceK103489 GE Veo Reconstruction OptionGeneral Electric Co. · 2011
  7. Descendant · cites it directly · 9 of its ownK133640 ASIR-VGe Medical Systems, LLC · 2014
  8. Descendant · 2 generations on · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
  9. Descendant · 3 generations on · 2 of its ownK213999 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022
  10. Descendant · 3 generations on · 1 of its ownK193170 Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019
  11. Descendant · 4 generations on · 0 of its ownK253686 True Definition DLGe Healthcare Japan Corporation · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014: 12019: 22020: 22021: 12022: 22023: 12026: 1
2014high 2 (2019) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all
  • K133640ASIR-VGe Medical Systems, LLC · 2014 · cites it directly9descendants
  • K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · 2 generations on8descendants
  • K213999Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022 · 3 generations on2descendants
  • K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019 · 3 generations on1descendant
  • K253686True Definition DLGe Healthcare Japan Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K013561Lightspeed 4.0 CT Scanner SystemGE Medical Systems20015
−4K030420Lightspeed 5.0 Computed Tomography SystemGE Medical Systems20034
−3K040372Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC20045
−2K061817Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC20061
−1K081105GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare20085
0 (this device)K103489GE Veo Reconstruction OptionGeneral Electric Co.2011—
+1K133640ASIR-VGe Medical Systems, LLC2014—
+2K183202Deep Learning Image ReconstructionGe Medical Systems, LLC2019—
+3K213999Deep Learning Image ReconstructionGe Medical Systems, LLC2022—
+3K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation2019—
+4K253686True Definition DLGe Healthcare Japan Corporation2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201920
202020
202110
202220
202310
202610
FIG. 1 — Lineage of K103489, 2001–2026Source: 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
*K081105GE Lightspeed CT750 HD (Lightspeed 8.0)
Summary page 2
…graphy X-ray System per 21 CFR892.1 750 Product Code: 90-JAK Predicate Device(s): GE Discovery CT750 HD (K081 105) 5-2 Manufacturer I…
GE Healthcare20085

Also cleared against K081105: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K133640ASIR-VGe Medical Systems, LLC20149

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?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 5 of the 5 ancestors have a recall of any class.
  • Of its descendants, K133640 (Ge Medical Systems, LLC, 2014) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K081105.

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. 2011, this device’s year, is highlighted.

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 Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages. When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography…

Read the full statement (137 words)

The Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages. When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from GE CT scanners. The Veo reconstruction option can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging, including CT scans of the head, chest, abdomen and pelvis. The Veo reconstruction option may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic. Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

Indications for use as stated in the FDA summary.

Also cleared against K081105

2 other devices cite the same predicate.

  • K120833Discovery CT750 HDGe Medical Systems, LLC · 20121 recall
  • K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc. · 2009

More from General Electric Co.

270 FDA decisions under this applicant name. See the company

  • K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008
  • K081921GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
  • K073297GE Logiq P6General Electric Co. · 20072 recalls
  • K072952GE EchopacGeneral Electric Co. · 2007
  • K072797GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact UltrasoundGeneral Electric Co. · 2007

Recent decisions in JAK

The JAK category page

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https://510kreport.com/device/K103489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K103489: GE Veo Reconstruction Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103489

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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