ML20198D383
| ML20198D383 | |
| Person / Time | |
|---|---|
| Issue date: | 07/01/1998 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Ray B AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20138M147 | List: |
| References | |
| SSD, NUDOCS 9812230070 | |
| Download: ML20198D383 (6) | |
Text
{{#Wiki_filter:.. /p purrgk p UNITED STATES g j NUCLEAR REGULATORY COMMISSION 2 WASHINGTON, D.C. 20086 0001 \\*****/ July 1, 1998 Bill Ray Program Manager, Installed Base i GE Medical Systems-Nuclear Medicino l l 3000 N. Grandview Blvd., W-C ? Waukesha, WI 53188
Dear Mr. Ray:
This letter is in response to your letter dated June 12,1998, and previous letters from GE Medical Systems providing additional information in support of your application. In order to complete our review, the following information needs to be adequately addressed: i 1. Please provide additional information about the frequency of required lubrication of the retraction springs to ensure the springs maintain their integrity. In addition, please commit to providing instructions to users concoming the need to lubricate the springs. 2. Due to the way in which the device is mounted to the gantry it may be subject to impact on a daily basis from accidental " bumping" by medical staff or patients, or from impact with equipment (e.g., hospital bed, wheel chair). In addition, it may be subjected to being dropped at installation or moving. Therefore, GE Medical Systems needs to provide information conceming drop testing of a prototype unit (i.e., procedures and results) or provide analysis that shows drops or impacts will not compromise the ] radiological safety of the device. 3. Please indicate who will be responsible for installation and removal of the collimator, the user or persons specifically licensed to perform such activity, in addition, please clarify the distinction between relocation of the device, which may be performed by the user, . and installation, which may only be performed by persons specifically licensed to perform such activity, as indicated in attachment 7, of GE Medical Systems' letter dated March 19,1998. 4. Based on review of GE Medical Systems' affidavit dated May 7,1998, NRC has determined that additional information is needed for the following pages: A10; B7, 89, B15-B18, B22-B88; E2; F2-F11, and F14. As indicated in the letter dated April 9,1998, from Steven Baggett, NRC,10 CFR j 2.790(b)(1)(ii) requires that a non-proprietary version of the information be submitted. In preparing the non proprietary version place brackets around the material considered to be proprietary, and white out or black out the proprietary portions, leaving the non-proprietary portions intact. With regard to the diagrams and blueprints,information typically considered to be proprietary includes information such as dimensional tolerances and specific manufacturing notes or details listed on the drawing. Any additionalinformation on the drawings would be releasable. In order to address this, please identify the specific j l information on each drawing that GE Medical Systems wishes to be held as proprietary. I l 9812230070 980810 l PDR RC MD PH
[ o 1 i r l L ' +, Bill Ray 2 ( i A proprietary version (with the brackets) and a non-proprietary version (with the marked out information) of each page referred above, and a new affidavit must be submitted prior to the staff making its final proprietary determination. In accordance with 10 CFR 2.790(c), the information sought to be withheld will be placed in the Commission's Public Document Room unless you provide the Commission with the requested information, or a request that the letter be withdraw, within thirty (30) days of the date of this letter. Please provide the requested information within thirty (30) days. If we do not receive the sufficient information within thirty (30) days, we will consider your application for registration of l the device as having been abandoned by you. This action is without prejudice to the l resubmission of a complete application. If you have any questions please contact me at (301) 415-7868 or Eric Compton at (301) 415-5799. L j Sincerely, L (orig. signed by) f John W. Lubinski, Mechanical Engineer l Materials Safety Branch Division of Industrial and Medical i Nuclear Safety Office of Nuclear Material Safety and Safeguards l i Distribution: IMNS r/f SSD-97-30 NE01 l DOCUMENT NAME: H:\\ERIC\\COMPLTR\\GEMED2.DEF Ta receive a copy of th6s document. Indicate in the boa: 'C' = Cory without attachment / enclosure
- E' = Copy with attachment / enclosure
- N* = No copy OFFICE MSB c MSB ;J e
NAME ECompton yt; JLubinsli DATE 07/ / /98 07/ ( /98 OFFICIAL RECORD COPY
April 10,1997 ASSIGNMENT NUMBER: 97-30 Mr. Thomas Demke G.E. Medical Systems General Electric Co. P.O. Box 414 Milwaukee, WI 53201
SUBJECT:
ACKNOWLEDGEMENT OF REQUEST FOR SAFETY EVALUATION
Dear Mr. Demke:
This letter acknowledges the receipt of your March 28,1997, application that requested a safety evaluation and registration of the Model 2180506. We have performed a cursory review of your application and determined that enough information has been provided to allow s. technical reviewer to initiate the evaluation process. Applications are assigned to technical reviewers on a first-in basis. Therefore, your application will be assigned in turn. Please note that the technical reviewer may contact you to request information that was omitted from your application or to obtain clarification of technicalissues concerning your application. If you have any questions concerning the status of your application, please contact me at (301) 415-7857. Please reference the assignment number listed above in your questions or correspondence. Please be aware that your request may be subject to the NRC's application fees in accordance with 10 CFR Part 170. Therefore, a copy of your application has been forwarded to the License Fee and Debt Collection Branch for approval of the fee category and amount. If you have any questions concerning the fees associated with your application, please contact the License Fee aM Debt Collection Branch at (301) 415-7554. Sincerely, /5/ KimBerly Randall, Registration Assistant Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution: SB:ggsM SSSS r/f 97-30 NEO1 4 7UMENT NAME: P:97-30 C:\\WPWIN60\\WPDOCS\\97-33.WPD I .lve a copy of this document, Indicate in the bes:
- C' = Copy without attachment / enclosure
'E' = Copy with attachment / enclosure
- N' = No copy UFFICE IMAB, j NAME KRarK DATE 4/ p/97
/ OFFICIAL RECORD COPY
\\ s l Is l CHECK NO. stat. l j 0012050785 ) curursusness szRwces.we. PO Box 00$00 FORTMYERs FL 33906-6500 MW=ias AM AN: OE MEDCAL SYSTEMS q 03/31/97 PAY: Three ThousandFourHundred AndNo/100 Dollars CifECK AMOUNT TO THE ORDER OF: UNITED STATES NUCLEAR REGULATORY COMMISSION OFF OF NUCLEAR MAT SAF & SAFEG WASHINGTON DC 20555- [ Authorized Signature sn e c ,mA - c - ) POO & 20 50 78 5e :01190044 5s: 4E493e T PAGE p_l, Control f 121 CLIENT BUSINESS SERVICES,INC. PO BOX 50600 As Disbursins Asas tbr: oE MEDICAL SY3f EMS FORT MYERS FL 339064600 (941) 418-6060 e ri e dh :t asi irupart n ini. viius,.ervice inne. our Autem ied service Line H,. bupio d r tti Favor dirigir cushpaer pregata al manero de kleibno indicato. Nuestra Linra Automwra de Servicio a Vendedores Ha MMt!!!! UNITED STATES NUCLEAR REGULATORY COMMISSION OFF OF NUCLEAR MAT SAF & SAFEG WASIIINGTON DC 20555-INVOICE NUMBER DATE VOUCllER GROSS ru 10UNr DISCOUNr NET AMOUNr v T0032797HR 03/27/97 A9C1HR 3400.00 0.00 3400.00 REGISTRATION OF DEVICE CIIECK NUMBER DATE VENDOR NO. NAME TOTAL. AMOUNr 0012050705 03/31/97 475528-00 UNITED STATES NUCLEAR 3400.00
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c, PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMIS$10N 4
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(' ~ REQUEST FOR A SEALED SOURCE OR g j DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of au related letters /apphcations and drawings to: The Sealed Source Safety Section, ATTN; CNef, OWFN Med Stop 8 H3. Change the License Tracidng System milestone to 19 and assign to reviewer code I-5. NOTE: Retain a copy of this request with the application and background files. REQUESTER 7 REGION / LOCATION: b ~/ /[( f/( li 11 lll IV UV U HQ LFOCB YELEPHONE NUMBER DATE / TYPE OF ACTION REQUESTED (Check as appropriate) '~ 7 % APPUCANTS NAME SOURCE 6EVIEW AMENDMENT OF gg g[ REGISTRATION SHEET (I MAit CourROL NUMBER (S) DEVICE REVIEW ~ LEITER /APPUiCAbDdTE97 A LK:ENSE NUMBER (S) CUSTOM REVIEW ~~ & 2 MMck( Sys/ein.s L Men / E/ec/m Co. N P.o.3 OX V W in:/w A a x v w1 SD tv FOR SSSS USE ONLY NEVIEWER MODEL NUMBERS NUMBER ASSIGNED &. $A p7 odd ewto5o& 97 SO 4l/O 17' 9llS/9f 4lSlf7 i DATE RECEIVED DATE ASSIGNED DATE TO FEES TYPE OF ACTION (Indicate the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) S SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98) NEW u NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j UCENSING ACTION REQUIRED IF KNOWN -j NO FEES REQUIRED NO j OTHER (Speelty) -{ TOTAL NUMBER OF NOTES s REVIEW HOURS NUMBER OF DEFICIENCY LETTERS 1 NUMBER OF -) DEFICIENCY CALLS ,j FOR BILLING PURPOSES ONLY NAME CHANGE ' ADDRESS CHANGE NEW REGISMON - ] MODUCT INACTIL ADD TO BILLING REMOVE FROM BILLING j FOR FEE USE ONLY TYPE FEE CATEGORY l9A 99 ~ 9C 9D 7$'Q7)o '"5'S75"2)50766 Z ^""js ^ l eO D DAM OF CHECK, LOG d mfd j TSYS UPDATED APPROVED BY DATE RETURN DATE -Nr. . NRC FORM 567 (843) G _m .h'.- - ___ - _ ?_ ?
PAGE1 NRC FORM 567 U, S. NUCLEAR REGULATORY COMMISSION
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REQUEST FOR A SEALED SOURCE OR g y DEVICE EVALUATION 4 INSTRUCTIONS: Send this regJost AND a copy of all related letters /appilcohons and drawings to: The Sealed Source Safety Sectkm, ATTN: CNef, OWFN Maa Stop 6 H3. Change the Ucense Tracidng System meestone to 19 and seeign to reviewer code I-5. NOTE: Retain a copy of tNs request with the appucation and back0round flies. REQUESTER REGION / LOCATION: b (M,*(g[ Mf ]l R11 111 R IV CV R HQ R LFDCB TELEPHONE NUMBER DATE / TYPE OF ACTION REQUESTED (Check as appropriate) CPPUCANTS NAME SOURCE REVIEW AMENDMENT OF UM_I 8' BER uAa. CONTROL NUMBERm DEVICE REVIEW WTTER/APPUCA DATEj UCENSE NUMBER @ CUSTOM REVIEW ' b/r2 / Y "~~ g 2 niercsf Sypun.s G<//W/ E&ckz Co-d. /m/w A a x ee, tn.1 DAct FOR 8488 USE ONLY HEVIEWER f MODEL NUMBERS NUMBER AS$1GNED & C' m L. /71oset c;7t r o s o e ??-30 'DATE RECEIVED / DATE ASSIGNED DATE TO FEES 4 I n)'t, 9/iski e/a/97 TYPE O, _ -. t _, t-l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) SOURCE (9C) DEVICE (9A) SOURCE (90) DEVICE (98) NEW u NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Spec #Y) TOTAL NUMBER OF ' NOTES REVIEW HOURS I NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS i FOR BILLING PURPOSES ONLY NEW REGISTRATIOh j PRODUCb,Tb-NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILUNG FOR FEE USE ONLY TYPE F j FEE CATEGORY l f/ ] 9A R 98 90 9D ^"f8'T3D 'T8/IMO E %I^"c"ufRED " ^ DATE McNECK 3/3/[97 g 4 M $1PL) ] MATSYS UPDATED LOG / AS REQUIRED APPROVED BY DATE RETURN DATE COMMENTS I NRC FORM $67 (&S3) NO j}}