510(k) · Cleared
Recalled · Class II · 2019Discovery Pet/CT 710
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 Mar 21, 2014 as substantially equivalent to K081496 (Ge Medical Systems, LLC, 2008) after a 114-day review. Its family tree reaches back 6 generations to 2001. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 21, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010641 (2001). 8 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 5 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 3 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 2 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 1 generation backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- This deviceK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014
- Descendant · cites it directly · 5 of its ownK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- Descendant · 3 generations on · 2 of its ownK221932 Omni LegendGE Healthcare · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK241266 Imaging system of positron emission and X-ray computed tomography…Raysolution Healthcare Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK241665 Omni LegendGe Medical Systems Israel, Functional Imaging · 2024 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161574Discovery MIGe Medical Systems, LLC · 2016 · cites it directly5descendants
- K211846Discovery MI Gen2Ge Medical Systems, LLC · 2021 · 2 generations on3descendants
- K221932Omni LegendGE Healthcare · 2022 · 3 generations on2descendants
- K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)Raysolution Healthcare Co., Ltd. · 2025 · 2 generations on0descendants
- K241665Omni LegendGe Medical Systems Israel, Functional Imaging · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −5 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −4 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −3 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −2 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −1 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| 0 (this device) | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | — |
| +1 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| +2 | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| +3 | K221932 | Omni Legend | GE Healthcare | 2022 | 1 |
| +2 | K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | 2025 | — |
| +4 | K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K081496 | Optima Pet/CT 560Summary page 1…) while maintaining acceptable image quality. Identification of Legally Marketed Equivalent Devices Discovery PET/CT 690 GE Medical Systems LLC K081496 5-2… | 2008 |
What descends from it? (7)
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-1746-2019 | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| Feb 12, 2019 | Class II | Z-1750-2019 | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| May 24, 2018 | Class II | Z-2579-2018 | Component change control | DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). |
| May 19, 2017 | Class II | Z-2191-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K161574 (Ge Medical Systems, LLC, 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K081496.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
GE PET/CT 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 systems 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 in patients of all ages. This can assist…
Read the full statement (125 words)
GE PET/CT 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 systems 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 in patients of all ages. 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 systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133657: Discovery Pet/CT 710.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133657
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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