# K962738: Millennium MT and Millennium MG Nuclear Medicine Systems

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 10, 1996 after 87 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 6 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915470 (1992). 4 ancestors in all.
16 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915470: Optima Nuclear Tomography Stystem, General Electric Co. (1992) Summary page 1.
- K951144: Phoenix Plus & Base Nuclear Medicine Single Detector Systems, GE Medical Systems (1995) Summary page 1.
- K924498: Maxxus, GE Medical Systems (1992) Summary page 1.
- K922080: Genesys II, Adac Laboratories (1992) Summary page 1.

## Most influential descendants
- K022240: Mobile Millennium MG System (2002), 11 descendants of its own
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own
- K051855: Ventri (2005), 3 descendants of its own

## Recalls of this device
- Sep 14, 2018 · Class I · Z-0369-2019: A detector can detach and fall.
- Sep 14, 2018 · Class I · Z-0370-2019: A detector can detach and fall.
- Sep 14, 2018 · Class I · Z-0371-2019: A detector can detach and fall.
- Apr 18, 2005 · Not classified · Z-0414-06: 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
- Apr 18, 2005 · Not classified · Z-0415-06: 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
- Apr 18, 2005 · Not classified · Z-0413-06: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K962738
Methodology: https://510kreport.com/methodology