ML20249A567
| ML20249A567 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Frappaola P FOOD & DRUG ADMINISTRATION |
| References | |
| SSD, NUDOCS 9806170078 | |
| Download: ML20249A567 (2) | |
Text
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y' et UNITED STATES
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E NUCLEAR REGULATORY COMMISSION gl3 ',E WASHINGTON D C. 20h0001 June 16, 1998 Philip J. Frappaola, Deputy Director Office of Compliance Center for Devices and Radiological Health Department of Health and Human Services Food ::nd Drug Administration 2098 Gaither Road Rockville, MD 20850
Dear Mr. Frappaola:
1 As agreed upon in the Memorandum of Understanding between the Nuclear Regulatory
{
Commission (NRC) and the Food and Drug Administration (FDA), we are informing FDA that J
NRC has received an application for registration of a product that may be regulated by both Agencies. The applicant has not indicated whether it has notified FDA. The table below includes a brief description of the application.
Applicant's Name and Address SMV America 8380 Darrow Road Twinsburg, Ohio 44087 Contact Name Mr. William J. Bishop V.P. Business Development I
I Contact Telephone Number 800-664-0844 I
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Source or Device Transmission Attenuation Correction (TAC) Source Holder Model PS 96 Isotope Gd-153 f
(
1 Activity max. 646 mci (two separate sources, g
323 mci each)
Intended Use Medical diagnostic imaging, the device is an accessory to gamma cameras New Application or Amendment New application Date of the Application March 7,1997 l
l 9806170078 980616 PDR RC SSD-98-38 PDR l
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'Brief Description of the Application:
'The TAC device provides, during image acquisition, a radiation beam (transmission) of l differing energy from that of the radiopharmaceutical administered intemally to the patient
'(emissicn) to reduce resolution losses normally experienced in nuclide tomcgraphy studies due to the non-uniform absorption characteristics of tissues surrounding the organ of interest in patient imaging. The TAC. device is designed as accessory equipment for use with gamma cameras manufactured by SMV.
If you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at
-(301) 415-7273.
Sincerely,
' John P. Jankovich, Ph.D., Sr. Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety
- Office of Nuclear Material Safety and Safeguards L Distribution:
SSSS r/f SSD-98-38 NEO1 b LCamper RAyres DOOUMENT NAME: ' H:\\SSDFILES\\ LETTERS \\NR104810.FDA To receive a copy of this document, Indicate in the bon: *C' = Copy without attachrreent/ enclosure "E" = Copy with attachment / enclosure "N' = No copy OFFICE IMNS i p l (, IMNS @
-F l
l NAME JJanipvich/jj/pf SBaggett DATE-06/ b/98 06//O /98 2
OFFICIAL RECORD COPY:
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