510(k) · Cleared
ClearedPhoenix Plus & Base Nuclear Medicine Single Detector Systems
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 Jul 3, 1995 after a 112-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.
- Decided
- Jul 3, 1995
- Review
- 112 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- 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 deviceK951144 Phoenix Plus & Base Nuclear Medicine Single Detector SystemsGE Medical Systems · 1995
- 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) | K951144 | Phoenix Plus & Base Nuclear Medicine Single Detector Systems | GE Medical Systems | 1995 | — |
| +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)
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 · 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/K951144 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951144: Phoenix Plus & Base Nuclear Medicine Single Detector Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951144
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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