510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

GE Lightspeed Act FP16

K091673510(k) TraditionalCleared Jun 24, 200915-day reviewClass II21 CFR 892.1750Recalls 1

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 24, 2009 as substantially equivalent to K012385 (Ge Medical Systems, Inc., 2001) after a 15-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.

Decided
Jun 24, 2009
Review
15 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K012385 (2001). No later device cites it as a predicate yet.

K012385 · Hispeed X/I Smart Gantry Option · Ge Medical Systems, Inc. · 2001200020022004200620082010
K012385 · Hispeed X/I Smart Gantry Option · Ge Medical Systems, Inc. · 20010
  1. Root · 1 generation backK012385 Hispeed X/I Smart Gantry OptionGe Medical Systems, Inc. · 2001
  2. This deviceK091673 GE Lightspeed Act FP16Ge Medical Systems, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012385Hispeed X/I Smart Gantry OptionGe Medical Systems, Inc.2001—
0 (this device)K091673GE Lightspeed Act FP16Ge Medical Systems, Inc.2009—
FIG. 1 — Lineage of K091673, 2001–2009Source: 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
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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
*K012385Hispeed X/I Smart Gantry Option
Summary page 1
…Comparison with Predicate Device: GE LightSpeed ACT FP16 is substantially equivalent in terms of safety and effectiveness to the GE HiSpeed X/i Smart Gantry Option (K012385). Both systems utilize a movable CT gantry to scan the patient while placed on a stationary table. They have the same tec…
Ge Medical Systems, Inc.2001—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 19, 2017Class IIZ-2187-2017Software designIt was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

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. 2009, 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 GE LightSpeed TM ACT FP16 is indicated for head and whole body X-ray computed tomography applications.

GE LightSpeed TM ACT FP16 is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, cardiology, diagnostic and interventional procedures, and optionally, rotational imaging procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.

Indications for use as stated in the FDA summary.

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
  • K082104GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT SystemGe Medical Systems, Inc. · 20081 recall
  • P870025/S008Fetal Acoustic StimulatorGe Medical Systems, Inc. · 2006

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https://510kreport.com/device/K091673 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091673: GE Lightspeed Act FP16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091673

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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