ML20203A316

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Responds to 980107 Application Requesting Registration of Our Xgd Rotating Gamma Sys,Model Ii.Deficiencies Noted in Application Are Listed to Be Reviewed & Addressed Before Submitting to State of Ny
ML20203A316
Person / Time
Site:
(SSD-2)
Issue date: 02/09/1998
From: Randall K
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Guo V
AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9802240001
Download: ML20203A316 (2)


Text

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WASHINGTON, D.C. 20565-0001 4 *****,o 9

February 9,1998 Ms. Vivian Guo, President OUR Scientific Intemational, Inc.

One World Trade Center Suite 7871 New York, NY 10348

Dear Ms. Guo:

This letter is in response to your application dated January 7,1998, requesting registration of OUR XGD Rotating Gamma System, Model 11. Please note that you are located in an Agreement State. Agreement States are responsible for performing the safety evaluation of products. You should submit your application to Ms. Rita Aldrich in the State of New York, Divisbn of Safety and Health, New York State Department of Labor, New York State Office Campus, Building 12, Room 457, Albany, NY 12240,(518) 457-1202. We did note some deficiencies in your application that you may want to review / address before submitting the application to the State of New York. These are as follows:

1.

Complete and detailed engineering drawings including dimensions, tolerances, materials of construction, and assembly methods (screw, welds, etc.).

2 A copy er description of the label, and describe the plaument, materials of construction and means of attachment of trie label.

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3.

The results of prototype testing that demonstrate the effectiveness of the containmert, shielding, and the safety features under both normal and likely accidental conditions of use and disposal of this product. Please provide the tests and procedures used.

4.

Radiation profiles around the device at of 5,30, and 100 cm.

S.

Describe what procedures are taken to ensure that your product is manufactured and distributed in accordance with the representations made in your application. Specific details of Quality Control and Quality Assurance program.

6.

Operations / Users / Safety inst uctions were not ine'uded in your application. Please provide instructions invoving the operation, maintenance, calibration, damage / failure, l

specific wamings, and radiation surveying of the product.

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2 We have enclosed NUREG-1550 and NUREG-1556 Vol.3 for your use.

Sincerely, db KimBerly Randall, Sealed Source Deuce Assistant Sealed Cource Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As stated cc: Rita Aldrich, State of New York Sandra Kimberley, LFDCB Richard Bangart, OSP Distribution:

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