(26 days)
No
The summary describes a standard SPECT imaging system and its components, focusing on image acquisition, display, processing, and archiving. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The processing mentioned is likely standard image reconstruction and manipulation techniques common in nuclear medicine.
No
The device is clearly stated as a "diagnostic imaging system" in its intended use, rather than a system for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as a diagnostic imaging system."
No
The device description explicitly lists hardware components such as a gantry, patient table, image acquisition hardware, operator console, and processing/review workstation. It is a complete imaging system, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system "produces images representative of the internal distribution of radioactivity in the head or body" when used with radiopharmaceuticals. This describes an in vivo diagnostic imaging system, where the diagnostic information is obtained from within the living body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
- Device Description: The description of the system components (gantry, patient table, etc.) aligns with an imaging system used on a patient, not a laboratory device for analyzing samples.
- Input Imaging Modality: SPECT (Emission Computed Tomography) is an imaging modality used to visualize the distribution of radioactive tracers within the body.
Therefore, the Mobile Millennium MG Imaging System is an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multi-slice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.
Product codes
90 KPS
Device Description
The GE Millennium Mobile MG System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, a processing and review workstation, and associated accessories. Materials and construction are equivalent to the Millennium MG System and eNTEGRA Workstation and are compliant with CISPR 11, IEC 801, UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
Key Metrics
Not Found
Predicate Device(s)
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
AUG 0 6 2002
Image /page/0/Picture/2 description: The image shows a circular pattern with a textured appearance. The pattern consists of small, irregular shapes and lines that create a dense, interwoven design. The overall effect is reminiscent of a close-up view of a natural surface, such as a sponge or a piece of coral. The image is monochromatic, with varying shades of gray that contribute to the texture and depth of the pattern.
GE Medical Systems
ELGEMS Ltd. 10 Hayozma St., P.O. Box 170 Tirat Hacarmel, 30200, Israel
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)
| Submitter: | GE Medical Systems
3000 N. Grandview Blvd.
Waukesha, WI 53188 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hemy Neuman
Quality, Safety and Regulatory Manager
Telephone: +972-4-856-3667; Fax: +972-4-857-7664 |
| Date Prepared: | June 16, 2002 |
| Device Name: | Millennium Mobile MG Imaging System.
Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | GE Medical System's Millennium MG System; 510(k) Number K962738
and eNTEGRA Processing and Review Workstation; 510(k) Number K000395, both currently in commercial distribution. |
Device Description:
The GE Millennium Mobile MG System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, a processing and review workstation, and associated accessories. Materials and construction are equivalent to the Millennium MG System and eNTEGRA Workstation and are compliant with CISPR 11, IEC 801, UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
Indications for Use:
The Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multislice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.
Comparison with Predicate Device:
The GE Millennium Mobile MG System is a modification of, and is comparable and substantially equivalent to the currently marketed GE Millennium MG System and the GE eNTEGRA Processing and Review Workstation. This system has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate devices.
Summary of Studies:
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
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K02240
Page 2 of 2
Conclusion:
Intended use and fundamental scientific technology are the legally marketed GE Millennium MG System and eNTEGRA Workstation. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the Millennium Mobile MG System is substantially equivalent to the currently cleared Millennium MG System and the eNTEGRA Workstation.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 6 2002
Dated: June 16, 2002 Received: July 11, 2002
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems W-709 P.O. Box 414 MILWAUKEE WI 53201
Re: K022240
Trade/Device Name: Millennium Mobile MG System and eNTEGRA Workstation Regulation Number: 21 CFR 892.1200 Regulation Name: Emmission computed tomography system Regulatory Class: II Product Code: 90 KPS
Dear Dr. Kroger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
. .
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Henry C. Brodin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INTENDED USE
KD22240 510(k) Numbér (if known):
Device Name: Millennium Mobile MG System and eNTEGRA Workstation
Indications for Use
The Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multi-slice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801-109)
OR
Over-The-Counter Use
David A. Seymore
(Division Sign-Off Division of Reproductive, Abdon and Radiological Devices h i l xkj Number