510(k) · Cleared

Recalled · Class I · 2018

Millennium MT and Millennium MG Nuclear Medicine Systems

K962738510(k) TraditionalCleared Oct 10, 199687-day reviewClass II21 CFR 892.1200Recalls 6 (3 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Medical Systems · KPS System, Tomography, Computed, Emission

Cleared on Oct 10, 1996 as substantially equivalent to K915470 (General Electric Co., 1992) and 3 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1992. 1 of the 21 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it. It has been recalled 6 times, including 3 Class I recalls.

Decided: Oct 10, 1996
Review: 87 days
Class: Class II
Product code: KPS
Recalls: 6 (3 Class I)
Predicates: 4

Its longest line of descent runs back 1 generation to K915470 (1992). 4 ancestors in all. 16 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK915470 Optima Nuclear Tomography StystemGeneral Electric Co. · 1992
This deviceK962738 Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996
Descendant · cites it directly · 11 of its ownK022240 Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002
Descendant · 2 generations on · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
Descendant · 3 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
Descendant · 4 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
Descendant · cites it directly · 3 of its ownK051855 VentriGe Medical Systems F.I. Haifa · 2005 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2002high 2 (2008) · low 0 (2003)2026

Most influential descendants

Showing 5 of 16 · See all

K022240Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002 · cites it directly11descendants
K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · 2 generations on10descendants
K102677Bodytom NL 4000Neurologica Corporation · 2011 · 3 generations on9descendants
K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 4 generations on4descendants
K051855VentriGe Medical Systems F.I. Haifa · 2005 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915470	Optima Nuclear Tomography Stystem	General Electric Co.	1992	—
0 (this device)	K962738	Millennium MT and Millennium MG Nuclear Medicine Systems	GE Medical Systems	1996	—
+1	K022240	Mobile Millennium MG System	Ge Medical Systems, Inc.	2002	—
+2	K090811	Inspira HD, Model: NL1000	Neurologica Corporation	2009	—
+3	K102677	Bodytom NL 4000	Neurologica Corporation	2011	—
+4	K170238	BodyTom Elite	Neurologica Corporation, A Subsidiary of Samsung Electronics	2017	—
+1	K051855	Ventri	Ge Medical Systems F.I. Haifa	2005	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K962738, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 18.7 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K915470	Optima Nuclear Tomography Stystem Summary page 1 …Systems 3000 N. Grandview Blvd. Waukesha, WI 53188 Marketed Devices Predicate Devices: System Manufacturer 510(k) # Optima Nuclear Medicine System GE Medical Systems K915470 Phoenix Nuclear Medicine System GE Medical Systems K951144 Maxxus Nuclear Medicine System GE Medical Systems K924498 Vertex Nucle…	General Electric Co.	1992	—
*	K951144	Phoenix Plus & Base Nuclear Medicine Single Detector Systems Summary page 1 …d Devices Predicate Devices: System Manufacturer 510(k) # Optima Nuclear Medicine System GE Medical Systems K915470 Phoenix Nuclear Medicine System GE Medical Systems K951144 Maxxus Nuclear Medicine System GE Medical Systems K924498 Vertex Nuclear Medicine System ADAC K922080 f’ ce Description ) illenn…	GE Medical Systems	1995	—
*	K924498	Maxxus Summary page 1 …# Optima Nuclear Medicine System GE Medical Systems K915470 Phoenix Nuclear Medicine System GE Medical Systems K951144 Maxxus Nuclear Medicine System GE Medical Systems K924498 Vertex Nuclear Medicine System ADAC K922080 f’ ce Description ) illennium MT Nuclear Medicine System will be used for general pu…	GE Medical Systems	1992	1
*	K922080	Genesys II Summary page 1 …Systems K915470 Phoenix Nuclear Medicine System GE Medical Systems K951144 Maxxus Nuclear Medicine System GE Medical Systems K924498 Vertex Nuclear Medicine System ADAC K922080 f’ ce Description ) illennium MT Nuclear Medicine System will be used for general purpose applications - planar, whole body and…	Adac Laboratories	1992	2

Also cleared against K915470: 1 other device →

What descends from it? (16)

See all 16

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022240	Mobile Millennium MG System	Ge Medical Systems, Inc.	2002	11
K051855	Ventri	Ge Medical Systems F.I. Haifa	2005	3

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 14, 2018	Class I	Z-0369-2019	Other	A detector can detach and fall.
Sep 14, 2018	Class I	Z-0370-2019	Other	A detector can detach and fall.
Sep 14, 2018	Class I	Z-0371-2019	Other	A detector can detach and fall.
Apr 18, 2005	Not classified	Z-0414-06	Other	In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could…
Apr 18, 2005	Not classified	Z-0415-06	Other	In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could…
Apr 18, 2005	Not classified	Z-0413-06	Other	In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could…

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K022240 (Ge Medical Systems, Inc., 2002) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K915470.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)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 Millennium MT and MG systems are designed to acquire data for whole body and multi-slice images. The Millennium MT and MG are intended for use as diagnostic imaging devices. When used with appropriate pharmaceuticals, they produce images representative of the internal distribution of radioactivity in head or body. These systems allow you to acquire data for high resolution three dimensional, static gated or dynamic images of biochemical and metabolic processes.

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/K962738 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962738: Millennium MT and Millennium MG Nuclear Medicine Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962738

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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