ML20196J634

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Returns Application for Registry of Sealed Source & Device Evaluation,As Requested
ML20196J634
Person / Time
Issue date: 07/01/1999
From: Kime T
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Enos G
AFFILIATION NOT ASSIGNED
Shared Package
ML20196J638 List:
References
SSD, NUDOCS 9907070374
Download: ML20196J634 (3)


Text

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July 1,1999 Gary W. Enos Hitachi Medical Corporation of America Nuclear Medicine Products Division 9177 Dutton Drive Twinsburg, OH 44087

Dear Mr. Enos:

~ As requested, we are returning your application for the registry of a sealed source and device evaluation. If you have any questions or need further assistance, please feel free to contact me at (301) 415-8140.

Sincerely, 3

Traci Kime, Registration Specialist Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As stated DISTRIBUTION:

NEO-2 SSD-11 1MNS r/f To receive a copy of this document, indicate in the box:

'C's Copy w/o att/ encl. 'E" = Copy w/att/ encl."N" = No copy OFC MStB NAME iTKime DATE 7/1/99 OFFICIAL RECORD COPY 70g37499o7og PDR L

NRC FORM 667 U.S. NUCLEAR REGULATORY COMM4SSION 11 1999)

^

REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this rerquest AND a copy of all related letters /apphcauons and crawings to the Chief Sealed Source Safety Section, OWFN Mall Stop O 6 H3. Change the License Tracking System milestone to 19 and assign to reviewer code 1-5.

NOTE: Retain a copy of this rL;uest with the application and background files.

REQUESTER KtGIUN/LUGAliUN.

Hitachi Medical Corporation of America I

ll Ill IV HQ LFARB TELEPHONE NUMSER DATE 330-405-3330 04/23/1999 TYPE OF ACTION REQUESTED (Check as appropriate) sEE or ArcucAur Gary W. Enos, General Manager

] SOURCE REVIEW g AMENDMENT OF REGISTRATION SHEET DEVICE REVIEW NUMBER (S)

LErrEsvaePv Atm DATE ucENsE NuMsEms>

n CUSTOM REVIEW 04/23/1999 LJ NR-1075-0-101-S ChENT4 Nuclear Medicine Products Division 9177 Dutton Drive Twinsburg, OH 44087 FOR SSSS USE ONLY I.EVIEWER MODEL NUMsEAS NUMBER ASSIGNED Seung Lee Convergence NUA 99-28 DATE RECENED DATE ASSaGNED DATE TO FEES 04/27/1999 04/27/1999 04/27/1999 TYPE OF ACTION (Indicate the number of each type)

Q COMMERCIAL DISTRIBUTION (FORMAL)

] USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C)

E NRCE (SA)

SOURCE (9D)

SOURCE (9B)

] NEW

[,NEW

] NEW NEW

] AMENDMENT p AMENDMENT

] AMENDMENT

] AMENDMENT NO SAFETY EVALUATION REQUIRED LICENSING ACTION YES NO FEES REQUIRED REQUIRED NO (IF KNOWN)

Q OTHER (Specify)

Payment received 4/27/99 in the amount of $3600.00 - Check #14977 TOTAL NUMBER OF wons REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR FEE USE ONLY rvce os rte ret vu WORT Mf 9A

] 98 9C

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<oo ylI9 APPROdD BY

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DATE OF TUR m,.

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NRc FORM 667 (11996) rn NILa UN RLGTGLLD Nta me kvm was cosegnea weig erw arme

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HITACHI SPECTRADigital Series CONVERGENCE

  • V2500sP Digital Dual Detector Gamma Camera System with NUAS Non-Uniform Attentuation Correction REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ: NR-1075-D-101-S DAT_fi: April 22,1999 DEVICE TYPE:Line Source Holder / Attenuation Correction Device Hitachi Medical Corporation of.Arnerica Nuclear Medicine Product Division 9177 Dutton Drive, Twinsburg, Ohio Registration: 1530450 a Division of Hitachi Medical Corporation of America 660 White Plains Road Tarrytown, N.Y.10591 Registration: 2434710 Manufacturing Establishrnent

Reference:

Hitachi Medical Corporation 1-1-14 Uchi Kanda, Chiyoda-Ku Tokyo, Japan 101 Registration: 8030405 Wilb Manufactut:ao Processes al Hitachi Medical Corporation Kashiwa Works 2-1, Shintoyofuta, Kashiwa-shi Chiba-ken,277, Japan 1

For inquiry

Contact:

Gary W. Enos (330) 405-3330 / Fax : (330) 405-3222 I

//

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