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 Medical Systems Israel, Functional Imaging · KPS System, Tomography, Computed, Emission
Cleared on Aug 8, 2024 as substantially equivalent to K221932 (GE Healthcare, 2022) after a 59-day review. Its family tree reaches back 10 generations to 2001. It has been recalled once.
- Decided
- Aug 8, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010641 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations between
- 3 generations backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- 1 generation backK221932 Omni LegendGE Healthcare · 2022 · Recalled
- This deviceK241665 Omni LegendGe Medical Systems Israel, Functional Imaging · 2024
Show all 10 generations
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 9 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 7 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 6 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 5 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 4 generations backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- 3 generations backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- 1 generation backK221932 Omni LegendGE Healthcare · 2022 · Recalled
- This deviceK241665 Omni LegendGe Medical Systems Israel, Functional Imaging · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −9 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −8 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −7 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −6 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −5 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −4 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| −3 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| −2 | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| −1 | K221932 | Omni Legend | GE Healthcare | 2022 | 1 |
| 0 (this device) | K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K221932 | Omni LegendSummary page 5…te Device Information Device Name Omni Legend Manufacturer GE Medical Systems Israel, Functional Imaging 510(k) number K221932 Regulation number 21CFR 892.1200 and 21CFR 892.1750 Product Code KPS and JAK… | 2022 |
| † | K223212 | Precision DL | 2023 |
| † | K161574 | Discovery MI | 2016 |
| † | K192686 | Revolution Maxima, Revolution Ace | 2019 |
| † | K180318 | PET Digital Gating | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K221932.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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/K241665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241665: 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/K241665
Report an extraction error
Are you the manufacturer?
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