510(k) · Cleared
Recalled · Class II · 2015GE Discovery ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPS System, Tomography, Computed, Emission
Cleared on Jun 22, 2004 as substantially equivalent to K022872 (General Electric Co., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 2001. 1 of the 401 devices in its family, counting itself, has a Class I recall. 396 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010641 (2001). 4 ancestors in all. 396 later devices descend from it, 3 citing it directly. 1 of the 401 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 2 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 1 generation backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- This deviceK041543 GE Discovery STGE Healthcare · 2004
- Descendant · cites it directly · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- Descendant · 2 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
Showing 5 of 396 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 396 · See all- K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · cites it directly380descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 2 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 3 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −2 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −1 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| 0 (this device) | K041543 | GE Discovery ST | GE Healthcare | 2004 | — |
| +1 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| +2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 12 | 0 |
| 2013 | 8 | 0 |
| 2014 | 16 | 0 |
| 2015 | 14 | 0 |
| 2016 | 17 | 0 |
| 2017 | 18 | 0 |
| 2018 | 26 | 0 |
| 2019 | 23 | 0 |
| 2020 | 32 | 0 |
| 2021 | 27 | 0 |
| 2022 | 33 | 0 |
| 2023 | 34 | 0 |
| 2024 | 31 | 0 |
| 2025 | 42 | 1 |
| 2026 | 37 | 0 |
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.
1 device in this family has a Class I recall. 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 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022872 | GE Road Warrior Pet CT Imaging SystemSummary page 1…ass: Class II Product Identification of Legally Marketed Equivalent Devices Product Name: GE Discovery ST 510(k) #: K022872 Product Name: GE Discovery LS 510(k) #: K040172 General Electric Company 3000… | 2002 |
| * | K040172 | Modification to GE Discovery LS SystemSummary page 1…uct Name: GE Discovery ST 510(k) #: K022872 Product Name: GE Discovery LS 510(k) #: K040172 General Electric Company 3000 N Grandview Blvd Waukesha, WI 53188 U.S.A. GE Healthcare… | 2004 |
What descends from it? (396)
See all 3963 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2015 | Class II | Z-2803-2015 | Process control | Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K042863 (Siemens Molecular Imaging, Ltd., 2004) has gone furthest, with 380 descendants of its own.
- 1 other device also cites its predicate K022872.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The GE Discovery ST system 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 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…
Read the full statement (125 words)
The GE Discovery ST system 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 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 system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041543: GE Discovery ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041543
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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