510(k) · Cleared
Recalled · Class II · 2016Modification to GE Discovery LS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · KPS System, Tomography, Computed, Emission
Cleared on Apr 7, 2004 as substantially equivalent to K023988 (GE Medical Systems, 2003) after a 72-day review. Its family tree reaches back 2 generations to 2001. 1 of the 466 devices in its family, counting itself, has a Class I recall. 463 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 7, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010641 (2001). 463 later devices descend from it, 4 citing it directly. 1 of the 466 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 1 generation backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- This deviceK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004
- Descendant · cites it directly · 396 of its ownK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- Descendant · 2 generations on · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 463 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 463 · See all- K041543GE Discovery STGE Healthcare · 2004 · cites it directly396descendants
- K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 2 generations on380descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −1 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| 0 (this device) | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | — |
| +1 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| +2 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| +3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +4 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 13 | 0 |
| 2013 | 10 | 0 |
| 2014 | 21 | 0 |
| 2015 | 14 | 0 |
| 2016 | 17 | 0 |
| 2017 | 22 | 0 |
| 2018 | 31 | 0 |
| 2019 | 23 | 0 |
| 2020 | 36 | 0 |
| 2021 | 31 | 0 |
| 2022 | 37 | 0 |
| 2023 | 38 | 0 |
| 2024 | 36 | 0 |
| 2025 | 51 | 1 |
| 2026 | 44 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023988 | GE Discovery LS SystemSummary page 1…duct Reason for 510(k) Submission Modification of legally marketed device. Identification of Legally Marketed Equivalent Devices GE Discovery LS System K023988 Device Description The Discovery LS is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. In… | 2003 |
What descends from it? (463)
See all 4634 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 |
|---|---|---|---|---|
| Feb 10, 2016 | Class II | Z-1049-2016 | Labeling design | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. |
| Feb 10, 2016 | Class II | Z-1050-2016 | Labeling design | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. |
| Feb 10, 2016 | Class II | Z-1052-2016 | Labeling design | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. |
| Jul 17, 2015 | Class II | Z-2801-2015 | Process control | Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. |
| Jul 17, 2015 | Class II | Z-2802-2015 | 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 · 10 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 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K041543 (GE Healthcare, 2004) has gone furthest, with 396 descendants of its own.
- 1 other device also cites its predicate K023988.
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 LS 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 LS 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 (124 words)
The GE Discovery LS 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 LS 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 LS 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.
https://510kreport.com/device/K040172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040172: Modification to GE Discovery LS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040172
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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