510(k) · Cleared
Recalled · Class II · 2019Optima Pet/CT 560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · KPS System, Tomography, Computed, Emission
Cleared on Jun 12, 2008 as substantially equivalent to K050559 (GE Medical Systems, 2005) after a 14-day review. Its family tree reaches back 5 generations to 2001. 10 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 12, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010641 (2001). 7 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 4 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 3 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 2 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 1 generation backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- This deviceK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008
- Descendant · cites it directly · 7 of its ownK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- Descendant · 4 generations on · 2 of its ownK221932 Omni LegendGE Healthcare · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK113408 Q. Freeze (Motion VUE2)Ge Medical Systems, LLC · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133657Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · cites it directly7descendants
- K161574Discovery MIGe Medical Systems, LLC · 2016 · 2 generations on5descendants
- K211846Discovery MI Gen2Ge Medical Systems, LLC · 2021 · 3 generations on3descendants
- K221932Omni LegendGE Healthcare · 2022 · 4 generations on2descendants
- K113408Q. Freeze (Motion VUE2)Ge Medical Systems, LLC · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −4 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −3 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −2 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −1 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| 0 (this device) | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | — |
| +1 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| +2 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| +3 | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| +4 | K221932 | Omni Legend | GE Healthcare | 2022 | 1 |
| +1 | K113408 | Q. Freeze (Motion VUE2) | Ge Medical Systems, LLC | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 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? (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 |
|---|---|---|---|
| * | K050559 | GE Discovery VCT SystemSummary page 1…whole body multislice CT diagnostic imaging system. Identification of Legally Marketed Equivalent Devices GE Healthcare Discovery VCT K050559 General Electric Company P.O. Box 414 Milwaukee, WI 53201… | 2005 |
What descends from it? (10)
2 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 |
|---|---|---|---|---|
| Feb 12, 2019 | Class II | Z-1747-2019 | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| Feb 12, 2019 | Class II | Z-1745-2019 | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| May 19, 2017 | Class II | Z-2190-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
| Feb 10, 2016 | Class II | Z-1051-2016 | Labeling design | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. |
| Nov 20, 2013 | Class II | Z-0981-2014 | Software Manufacturing/Software Deployment | GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690. |
| Mar 26, 2013 | Class II | Z-0024-2014 | Software design (manufacturing process) | GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and… |
| Jul 25, 2011 | Class II | Z-1188-2013 | Process control | Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K133657 (Ge Medical Systems, LLC, 2014) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K050559.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 XR and XA Systems are 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 XR and XA are 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…
Read the full statement (129 words)
The GE Discovery XR and XA Systems are 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 XR and XA are 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. These devices can also assist in radiotherapy planning.
The Discovery XR and XA can also be used as stand-alone head and whole
body multislice computed tomography (CT) diagnostic imaging systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081496 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081496: Optima Pet/CT 560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081496
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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