(87 days)
Not Found
No
The summary describes a standard nuclear medicine imaging system and its functionalities, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The 'Intended Use / Indications for Use' section explicitly states that the Millennium MT and MG are intended for use as "diagnostic imaging devices," and they "produce images representative of the internal distribution of radioactivity" for "biochemical and metabolic processes." This indicates a diagnostic purpose rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Millennium MT and MG are intended for use as diagnostic imaging devices."
No
The device description explicitly details hardware components like detectors, gantry, and a locking motor, indicating it is a physical system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states the Millennium MT and MG systems are "diagnostic imaging devices" that "produce images representative of the internal distribution of radioactivity in head or body." This involves imaging the patient directly using nuclear medicine techniques, not analyzing samples taken from the patient.
- Intended Use: The intended use is for "acquiring data for whole body and multi-slice images" and "diagnostic imaging." This aligns with in-vivo imaging, not in-vitro testing.
The device is a nuclear medicine imaging system, which is a type of medical imaging device used for in-vivo diagnosis.
N/A
Intended Use / 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.
Product codes
21 CFR 892.1200
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 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 Millenneum 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine Imaging
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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.
Key Metrics
Not Found
Predicate Device(s)
K915470, K951144, K924498, K922080
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and surrounded by a circular design. The letters and the surrounding design are black, creating a strong contrast against the white background.
OCT 1 1996
GE Medical Systems
General Electric Company PO. Box 414, Milwaukee, Wi 53201
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) sammary 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: | (414) 544-3894 |
| Fax: | (414) 544-3863 |
| Date Of Preparation: | June 28. 1996 |
Identification Of The Product
Device Proprietary Name:
Common Name: Classification Name: Millennium MT and Millennium MG Nuclear Medicine Systems. Nuclear Medicine Scanner. 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
1
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 Millenneum 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.