ML20248B960
| ML20248B960 | |
| Person / Time | |
|---|---|
| Issue date: | 05/29/1998 |
| From: | Bhachu U NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Frappaola P FOOD & DRUG ADMINISTRATION |
| References | |
| SSD, NUDOCS 9806020029 | |
| Download: ML20248B960 (2) | |
Text
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May 29,-1998-l l.-.
. Philip J. Frappaola, Depoty Director
. Omco of Compliance Center for Devices and Radiological Health '
Department of Health and Human Services Food and Drug Administration L
2090 Gaither Road
' Rockville, MD ' 20850
Dear Mr. Frappaola:
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As agreed upon in the Memorandum of Understanding between the Nuclear Regulatory i.
Commission (NRC) and the Food and Drug Administration (FDA), we are informing FDA that l;
. NRC has received an application for registration of a product thai may be regulated by both i-
~ Agencies. The applicant indicated that it has notified FDA. Please see the enclosure to this
[
letter which includes a brief description of the application.
- If you have any questions, please contact me at (301) 415-7894 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, J
}%k hachu, Mechanical Engineer
)
Materials Safety Branch l
Division of Industrial and l
Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
Description of Application
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'E' = Copy with attechment/ enclosure
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NAME UBhachu ///h SBagg6tt DATE 4/M198 f/2#98
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OPPICIAL RECORD COPY i
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. -.c ENCLOSURE ELGEMS V-Transact Rod Unit-Attenuation Correction System.
Applicant's Name and Address Eigems Ltd. Tirat Hacamel, Israel.
Contact Name Tom Demke Contact Telephone Number-1-414-544-3915 Source or Device Device / V-Transact Isotope Gadolinium 153 Activity Two Housing Unit-Total 900 mci intended Use General Medical Use -Code V.
New Application or Amendment New Application.
l Date of the Application March 25,1998 Brief Description of the Application: A Dual Head Nuclear Medicine Imaging System. The device is installed on the base unit which is mounted to a dual-head camera gantry. Two source housing bases are permanently mounted to the gantry and rotate with the gantry during tomography scan. Step and l
Shoot and attenuation options provide the means to factor in body tissues f
attenuation affects to the CT Scans and SPECT images.
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