510(k) · Cleared
ClearedDiscovery MI Gen2
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 Aug 20, 2021 as substantially equivalent to K161574 (Ge Medical Systems, LLC, 2016) after a 66-day review. Its family tree reaches back 8 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 20, 2021
- Review
- 66 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010641 (2001). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 7 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 6 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 5 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 4 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 3 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 2 generations backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- 1 generation backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- This deviceK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- Descendant · cites it directly · 2 of its ownK221932 Omni LegendGE Healthcare · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK241665 Omni LegendGe Medical Systems Israel, Functional Imaging · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK223212 Precision DLGE Healthcare · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −7 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −6 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −5 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −4 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −3 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −2 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| −1 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| 0 (this device) | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| +1 | K221932 | Omni Legend | GE Healthcare | 2022 | 1 |
| +2 | K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024 | 1 |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 18.7 · 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 |
|---|---|---|---|
| * | K161574 | Discovery MISummary page 6…GE Medical System, LLC. 3000 North Grandview Blvd Waukesha, WI 53188 510(k) number K161574 cleared on August 11, 2016 Regulation number Emission Computed Tomography System per 21CFR 892.1200 /product Code… | 2016 |
| † | K131576 | Optima CT660 | 2013 |
| † | K193170 | Deep Learning Image Reconstruction | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221932 | Omni Legend | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 10 ancestors have a recall of any class.
- Of its descendants, K221932 (GE Healthcare, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K161574.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 MI Gen2 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. Discovery MI Gen2 is intended to image the whole…
Read the full statement (304 words)
The GE Discovery MI Gen2 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.
Discovery MI Gen2 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’s disease
» Non-Hodgkin’s lymphoma
* Colorectal Cancer
* Melanoma
Discovery MI Gen2 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211846 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211846: Discovery MI Gen2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211846
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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