510(k) · Cleared
ClearedMobile Millennium MG System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Aug 6, 2002 as substantially equivalent to K962738 (GE Medical Systems, 1996) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1992. 1 of the 18 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Aug 6, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915470 (1992). 6 ancestors in all. 11 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK915470 Optima Nuclear Tomography StystemGeneral Electric Co. · 1992
- 1 generation backK962738 Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Recalled (Class I)
- This deviceK022240 Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
- Descendant · 2 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · 3 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- Descendant · 4 generations on · 2 of its ownK213649 BodyTom 64Neurologica Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…direct predicate · 1996
Most influential descendants
Showing 5 of 11 · See all- K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · cites it directly10descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · 2 generations on9descendants
- K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 3 generations on4descendants
- K213649BodyTom 64Neurologica Corporation · 2022 · 4 generations on2descendants
- K131431Airo CT SystemMobius Imaging, LLC · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915470 | Optima Nuclear Tomography Stystem | General Electric Co. | 1992 | — |
| −1 | K962738 | Millennium MT and Millennium MG Nuclear Medicine Systems | GE Medical Systems | 1996 | Class I |
| 0 (this device) | K022240 | Mobile Millennium MG System | Ge Medical Systems, Inc. | 2002 | — |
| +1 | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
| +2 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +3 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| +4 | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| +3 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K962738 | Millennium MT and Millennium MG Nuclear Medicine SystemsSummary page 1…maging System. Emission Computed Tomography System, 21 CFR 892.1 200,9O-KPS Marketed Device: GE Medical System’s Millennium MG System; 51O(k) Number K962738, and eNTEGRA Processing and Review Workstation; 51O(k) Number K000395, both currently in commer… | 1996 |
| * | K000395 | Einstein Processing and Review WorkstationSummary page 1…d Device: GE Medical System’s Millennium MG System; 51O(k) Number K962738, and eNTEGRA Processing and Review Workstation; 51O(k) Number K000395, both currently in commercial distribution. Device Description: The GE Millennium Mobile MG System is composed of a gantry, pati… | 2000 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090811 | Inspira HD, Model: NL1000 | 2009 | 10 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090811 (Neurologica Corporation, 2009) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K962738.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multi-slice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022240: Mobile Millennium MG System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022240
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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