510(k) · Cleared
Recalled · 2006GE Discovery VCT 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 Mar 17, 2005 as substantially equivalent to K041543 (GE Healthcare, 2004) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 2001. 13 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010641 (2001). 6 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 3 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 2 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 1 generation backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- This deviceK050559 GE Discovery VCT SystemGE Medical Systems · 2005
- Descendant · cites it directly · 10 of its ownK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- Descendant · 2 generations on · 7 of its ownK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- Descendant · 4 generations on · 3 of its ownK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- Descendant · 5 generations on · 2 of its ownK221932 Omni LegendGE Healthcare · 2022 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K081496Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · cites it directly10descendants
- K133657Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · 2 generations on7descendants
- K161574Discovery MIGe Medical Systems, LLC · 2016 · 3 generations on5descendants
- K211846Discovery MI Gen2Ge Medical Systems, LLC · 2021 · 4 generations on3descendants
- K221932Omni LegendGE Healthcare · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −3 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −2 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −1 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| 0 (this device) | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | — |
| +1 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| +2 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| +3 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| +4 | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| +5 | K221932 | Omni Legend | GE Healthcare | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
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 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 |
|---|---|---|---|
| * | K041543 | GE Discovery STSummary page 1…missionn Modification of a legally marketed device. Identification of Legally Marketed Equivalent Devices GE Discovery ST System K041 543 GE Discovery ST System with Alternate Detector Option K042257 Deic Dscipio… | 2004 |
| * | K042257 | Discovery ST Pet/CT Imaging System with an Alternate Detector OptionSummary page 1…Legally Marketed Equivalent Devices GE Discovery ST System K041 543 GE Discovery ST System with Alternate Detector Option K042257 Deic Dscipio and Positron The Discovery VCT is an… | 2004 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2006 | Not classified | Z-0806-2007 | Other | Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K081496 (Ge Medical Systems, LLC, 2008) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K041543.
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 VCT 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 VCT 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 VCT 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 VCT 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 VCT 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/K050559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050559: GE Discovery VCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050559
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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