510(k) Report

510(k) · Cleared

Recalled · 2006

Discovery ST Pet/CT Imaging System with an Alternate Detector Option

K042257510(k) SpecialCleared Sep 8, 200419-day reviewClass II21 CFR 892.1200Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

General Electric Co. · KPS System, Tomography, Computed, Emission

Cleared on Sep 8, 2004 as substantially equivalent to K010641 (Ge Medical Systems, Inc., 2001) after a 19-day review. Its family tree reaches back 1 generation to 2001. 14 later devices descend from it. It has been recalled once.

Decided
Sep 8, 2004
Review
19 days
Class
Class II
Product code
KPS
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K010641 (2001). 14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 2 descendants cleared2015: 1 descendant cleared2014: 2 descendants cleared2012: 1 descendant cleared2021: 2 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant clearedK010641 · GE CT-Pet System · Ge Medical Systems, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 2 descendants K010641 · GE CT-Pet System · Ge Medical Systems, Inc. · 20010+5
  1. Root · 1 generation backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
  2. This deviceK042257 Discovery ST Pet/CT Imaging System with an Alternate Detector OptionGeneral Electric Co. · 2004
  3. Descendant · cites it directly · 13 of its ownK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
  5. Descendant · 3 generations on · 7 of its ownK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
  6. Descendant · 4 generations on · 5 of its ownK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
  7. Descendant · 5 generations on · 3 of its ownK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2005: 12008: 22012: 12014: 22015: 12016: 12021: 22022: 12023: 12024: 12025: 1
2005high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 14 · See all
  • K050559GE Discovery VCT SystemGE Medical Systems · 2005 · cites it directly13descendants
  • K081496Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · 2 generations on10descendants
  • K133657Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · 3 generations on7descendants
  • K161574Discovery MIGe Medical Systems, LLC · 2016 · 4 generations on5descendants
  • K211846Discovery MI Gen2Ge Medical Systems, LLC · 2021 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010641GE CT-Pet SystemGe Medical Systems, Inc.2001—
0 (this device)K042257Discovery ST Pet/CT Imaging System with an Alternate Detector OptionGeneral Electric Co.2004—
+1K050559GE Discovery VCT SystemGE Medical Systems20051
+2K081496Optima Pet/CT 560Ge Medical Systems, LLC20087
+3K133657Discovery Pet/CT 710Ge Medical Systems, LLC20144
+4K161574Discovery MIGe Medical Systems, LLC20163
+5K211846Discovery MI Gen2Ge Medical Systems, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200820
201210
201420
201510
201610
202120
202210
202310
202410
202510
FIG. 1 — Lineage of K042257, 2001–2025Source: 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 KPS? 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 KPS device

  1. #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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
*K010641GE CT-Pet System
Summary page 1
…mputed Tomography System, 21 CFR 892.1200, 90-KPS Marketed Device: GE Medical Systems GE Discovery ST Positron Emission Tomography System, 510(k) Number K010641, currently in commercial distribution. Device Description: The Discovery ST PET/CT Imaging System an with alternate detector opti…
Ge Medical Systems, Inc.2001—

Also cleared against K010641: 3 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K050559GE Discovery VCT SystemGE Medical Systems200513

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 26, 2006Not classifiedZ-0588-06OtherThe LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K050559 (GE Medical Systems, 2005) has gone furthest, with 13 descendants of its own.
  • 3 other devices also cite its predicate K010641.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007: 82008: 172009: 92010: 32011: 72012: 62013: 112014: 112015: 32016: 112017: 112018: 132019: 32020: 122021: 152022: 52023: 122024: 112025: 122026 (partial year): 6
2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007: 38 days median2008: 25 days median2009: 42 days median2010: 91 days median2011: 28 days median2012: 94 days median2013: 84 days median2014: 92 days median2015: 112 days median2016: 65 days median2017: 104 days median2018: 59 days median2019: 60 days median2020: 72 days median2021: 66 days median2022: 60 days median2023: 63 days median2024: 59 days median2025: 65 days median2026 (partial year): 67 days median
2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007: 222008: 162009: 142010: 42011: 342012: 132013: 132014: 182015: 52016: 162017: 112018: 12, 3 Class I2019: 5, 5 Class I2020: 82021: 42022: 8, 6 Class I2023: 6, 3 Class I2024: 152025: 162026 (partial year): 6
2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007: 382008: 112009: 152010: 442011: 562012: 342013: 2402014: 332015: 242016: 102017: 312018: 262019: 1052020: 222021: 102022: 152023: 222024: 232025: 36
2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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
20078382238
200817251611
20099421415
2010391444
20117283456
20126941334
2013118413240
201411921833
20153112524
201611651610
2017111041131
2018135912 (3)26
20193605 (5)105
20201272822
20211566410
20225608 (6)15
202312636 (3)22
202411591523
202512651636
20266676—

What is it indicated for?

The GE Discovery ST System with the alternate detector option is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST with alternate detector option is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic…

Read the full statement (137 words)

The GE Discovery ST System with the alternate detector option is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery ST with alternate detector option is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.

The Discovery ST with alternate detector option can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system

Indications for use as stated in the FDA summary.

Also cleared against K010641

3 other devices cite the same predicate.

  • K023988GE Discovery LS SystemGE Medical Systems · 20031 recall
  • K022872GE Road Warrior Pet CT Imaging SystemGeneral Electric Co. · 2002
  • K013521Gemini Imaging SystemAdac Laboratories · 20012 recalls

More from General Electric Co.

270 FDA decisions under this applicant name. See the company

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  • K081921GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
  • K073297GE Logiq P6General Electric Co. · 20072 recalls
  • K072952GE EchopacGeneral Electric Co. · 2007

Recent decisions in KPS

The KPS category page

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia…Siemens Medical Solutions USA, Inc. · 2026
  • K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K042257 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042257: Discovery ST Pet/CT Imaging System with an Alternate Detector Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042257

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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