510(k) · Cleared
Recalled · Class II · 2025Maxxus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · KPS System, Tomography, Computed, Emission
Cleared on Dec 3, 1992 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 1992
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 0
17 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.
- This deviceK924498 MaxxusGE Medical Systems · 1992
- Descendant · cites it directly · 16 of its ownK962738 Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK022240 Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002
- Descendant · 3 generations on · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
- Descendant · 4 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · 5 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…cites it directly · 1996
Most influential descendants
Showing 5 of 17 · See all- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · cites it directly16descendants
- K022240Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002 · 2 generations on11descendants
- K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · 3 generations on10descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · 4 generations on9descendants
- K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924498 | Maxxus | GE Medical Systems | 1992 | — |
| +1 | K962738 | Millennium MT and Millennium MG Nuclear Medicine Systems | GE Medical Systems | 1996 | Class I |
| +2 | K022240 | Mobile Millennium MG System | Ge Medical Systems, Inc. | 2002 | — |
| +3 | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
| +4 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +5 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 1 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962738 | Millennium MT and Millennium MG Nuclear Medicine Systems Class I | 1996 | 16 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2025 | Class II | Z-1047-2026 | Package design/selection | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been… |
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 · Cites it directly · ◆ in the 1996 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K962738 (GE Medical Systems, 1996) has gone furthest, with 16 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.
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 | — |
https://510kreport.com/device/K924498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924498: Maxxus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924498
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026