MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS

K962738 · GE Medical Systems · KPS · Oct 10, 1996 · Radiology

Device Facts

• Record ID: K962738
• Device Name: MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
• Applicant: GE Medical Systems
• Product Code: KPS · Radiology
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended 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.

Device Story

Nuclear medicine scanners (MT and MG models) acquire data from radio-labeled pharmaceuticals to produce planar, whole body, and SPECT images. Systems utilize two rectangular detectors in 180-degree geometry; MG model adds 101.25-degree cardiac detector angulation via locking motor and automated positioning software. Operated by clinicians in clinical settings; gantry/detector assembly supports various patient positions (prone, supine, sitting, sideways). Output consists of high-resolution images representing internal radioactivity distribution, aiding clinical assessment of biochemical/metabolic processes. MT system upgradeable to MG via hardware/software addition.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design comparison and intended use.

Technological Characteristics

Nuclear medicine scanner with two rectangular detectors. Supports planar, whole body, and SPECT imaging. MG model includes locking motor for 101.25-degree cardiac detector angulation. Gantry/detector assembly supports step-and-shoot, continuous, and elliptical tomography. Software-controlled positioning and setup protocols.

Indications for Use

Indicated for diagnostic imaging of internal radioactivity distribution in head or body to produce 3D, static, gated, or dynamic images of biochemical and metabolic processes in patients requiring nuclear medicine studies.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Optima Nuclear Medicine System (K915470)
• Phoenix Nuclear Medicine System (K951144)
• Maxxus Nuclear Medicine System (K924498)
• Vertex Nuclear Medicine System (K922080)

Submission Summary (Full Text)

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OCT 10 1996
K962738
GE Medical Systems
General Electric Company
P.O. Box 414, Milwaukee, WI 53201

# SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 (h).

## Identification Of Submitter

Submitter: Larry A. Kroger, Ph.D
GE Medical Systems
3000 N. Grandview Blvd., W-709
Waukesha, WI 53188

Telephone: [phone]
Fax: [phone]
Date Of Preparation: June 28, 1996

## Identification Of The Product

Device Proprietary Name: Millennium MT and Millennium MG Nuclear Medicine Systems.
Common Name: Nuclear Medicine Scanner.
Classification Name: Emission Computed Tomography System, 21 CFR 892.1200.

Establishment Reg. Number: 2126677
Manufacturing Location: GE Medical 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 Nuclear Medicine System | ADAC | K922080 |

## Device Description

Millennium MT Nuclear Medicine System will be used for general purpose applications - planar, whole body and SPECT (Single Photon Emission Computed Tomography). It will support two Digital CSE (correlated signal enhancement) rectangular detectors in 180 degree (opposed) geometry (DH position). Whole body studies will be accomplished through the gantry ring. The gantry/detector assembly will support step-and-shoot

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Summary Of Safety And Effectiveness
Millennium MT/MG
Page 2

tomography, continuous tomography, elliptical tomography, simultaneous anterior/posterior whole body and whole body contour applications. Prone/supine/sitting/sideways patient studies will be accommodated by the gantry/detector assembly.

In addition to the Millennium MT capabilities, the Millennium MG provides a 101.25 degree cardiac detector angulation (VG position) functionality implemented through the addition of a locking motor, additional software to automate the positioning and set up protocols.

The MT system can be upgraded to a MG system by adding a locking motor to the gantry and removing software locks to enable all of the MG software functionality

## 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.

## Comparison With Predicate Device

The Millennium MT/MG, and predicate devices are nuclear imaging systems which acquire information from radio-labeled pharmaceuticals and display images. A comparison of the features indicates that the Millennium MT/MG have the same intended use as the predicate devices. No new safety or effectiveness concerns are raised by the design of the Millennium MT/MG. It shares common hardware with the Phoenix system.

## Summary Of Studies

Initial information indicates that the Millennium systems will conduct planar, whole body, SPECT, tomographic and cardiac imaging. Cardiac studies can be accomplished through use of variable geometry detectors (MG model), which can be positioned at the 101.25 degrees to one another.

## Conclusions

In the opinion of GE Medical Systems, the Millennium MT/MG are substantially equivalent to the Optima, Phoenix and Maxxus Nuclear Medicine Systems manufactured by GE Medical Systems (510(k) #'s K915470 and K951144 and K924498 respectively), and the ADAC Vertex (510(k) # K922080). The Millennium MT/MG have the same intended use as the predicate devices. No new safety or effectiveness concerns are raised by the design of the Millennium MT/MG.