510(k) · Cleared
Recalled · Class II · 2025Omni Legend
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 Sep 2, 2022 as substantially equivalent to K211846 (Ge Medical Systems, LLC, 2021) after a 63-day review. Its family tree reaches back 9 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 2022
- Review
- 63 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010641 (2001). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- 2 generations backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- 1 generation backK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- This deviceK221932 Omni LegendGE Healthcare · 2022
- Descendant · cites it directly · 0 of its ownK241665 Omni LegendGe Medical Systems Israel, Functional Imaging · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK223212 Precision DLGE Healthcare · 2023
Show all 9 generations
- Root · 9 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 8 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 7 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 6 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 5 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 4 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 3 generations backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- 2 generations backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- 1 generation backK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- This deviceK221932 Omni LegendGE Healthcare · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −8 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −7 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −6 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −5 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −4 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −3 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| −2 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| −1 | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| 0 (this device) | K221932 | Omni Legend | GE Healthcare | 2022 | — |
| +1 | K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024 | 1 |
| +1 | K223212 | Precision DL | GE Healthcare | 2023 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K211846 | Discovery MI Gen2Summary page 5…JAK Predicate Device Information Device Name Discovery MI Gen2 Manufacturer GE Medical System, LLC. 510(k) number K211846 Regulation number 21CFR 892.1200 and 21CFR 892.1750 Product Code 90 KPS and 90 JAK Reference Devic… | 2021 |
| † | K161574 | Discovery MI | 2016 |
| † | K141477 | Discovery IQ | 2014 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Dec 24, 2025 | Class II | Z-1112-2026 | Software design | There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 11 ancestors have a recall of any class.
- Of its descendants, K241665 (Ge Medical Systems Israel, Functional Imaging, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Omni Legend is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages. Omni Legend is intended to image the whole body, head…
Read the full statement (301 words)
The GE Omni Legend is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.
Omni Legend is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).
When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology.
Examples of which are:
Cardiology:
• Cardiovascular disease
• Myocardial perfusion
• Myocardial viability
• Cardiac inflammation
• Coronary artery disease
Neurology:
• Epilepsy
• Dementia, such as Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, and frontotemporal dementia
• Movement disorders, such as Parkinson’s and Huntington’s disease
• Tumors
• Inflammation
• Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• Traumatic Brain Injury (TBI)
Oncology/Cancer:
• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Breast Cancer
• Prostate Cancer
• Hodgkin disease
• Non-Hodgkin lymphoma
• Colorectal Cancer
• Melanoma
Omni Legend is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system’s cleared indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221932: Omni Legend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221932
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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