ML20203A714

Corrected Registry of Radioactive Sealed Sources & Devices, SE of X-Ray Fluorescence Analyzer for Model Courier 20. Certificate:NR-701-D-103-B

ML20203A714
Person / Time
Issue date:	02/17/1997
From:	NRC
To:
Shared Package
ML20203A690	List: ML20203A686 ML20203A714
References
SSD, NUDOCS 9802240099
Download: ML20203A714 (1)

Text

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Corrected page: address change only, February 17, 1997)

NO,: NR-701-D-103-B DATE- September 29, 1995 PAGE 1 OF 7 DEVICE TYPE: X-Ray Fluorescence Analyzer MODEL: Courier 20 DISTRIBUTOR: Metorex Inc.

(formerly Outokumpu Electronic, Inc.)

Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618 MANUFACT'JRER : Metorex Ir.';rnatic nal, Cy (formerly Outokumpu Instruments, Oy)

P.O. Box 85 SF-02201 Espoo, Finland SEALED SOURCE MODEL DESIGNATION: Amersham: IEC.A1, CUC.A1N, CUC.A1, AMC.A1, or CLC.Al ISOTOEE1 MAXIMUM ACTIVITY:

Americium-241 30 mci (1.11 GBq), (AMC.A1)

Cedmium-109 20 mci (0.74 GBq), (CUC.A1N or CUC.A1)

Curium-244 100 mci (3.7 GBq), (CLC.A1)

Iron-55 2 0 0 '..Ci (7.4 GBq), (IEC.A1)

LEAK TEST FREOUENCY: 6 Months PRINCIPAL USE: (U) X-Ray Florescence CUSTOM DEVICE: YES X NO 9002240099 980218 PDR RC

• SSD PDR ..

I I

October 31,1997 i l

l ASSIGNMENT NUMBER: 97-64,97-65,97 66 Dr. Stanislaw Piorek i Metorex, Inc.

, Princeton Crossroads C orate Center P.O. Box 3540 l

! Prirneton, NJ 08543-3540

SUBJECT:

ACKNOWLEDGEMENT OF REQUEST FOR SAFETY EVALUATION

Dear Dr. Piorek:

i This letter acknowledges the receipt of your October 16,1997, application that requested a

, safety evaluation and registration of various Model numbers. We have performed a cursory i

review of your application and determined that enough information has been provided to allow a technical re jewer to initiate the evaluatien pr ocoss. Applications are assigned to technical

reviewers on a first-in basis. Therefore, your application will be assigned in turn. Pleaso note that the technical reviewer may contact you to request information that was omitted from your application or to obtain clarification of technicalissues conceming your application. If you have any questions concerning the status of your application, please contact me at (301) 415-8140.

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 and Debt Collection Branch at (301) 415-7554.

r Sincerc'y, KimBerly Randall, Registration Assistant

, Sealed Source Safety Section Medical, Academic, and Commercial i

Use Safety Branch Division ofIndustrial and Medical Nuclear Safety

+ Office of Nuclear Material Safety and Safeguards Distribution:

SSSS r# SSD-97-64 + 07 65 5 i SBaggett NE01 97-66 DOCUMENT NAME:P:97-64-66.wpd To receive e copy of this document, indicate in the box: *C' - Copy wthout ettschment/ enclosure 'E' = Copy eth attachinent/ enclosure 'N' = No copy OFFICE IMAB _

l l l l NAME KRandalP

~DATE 10//f /97 OFFICIAL RECGRD COPY

.W',% jy[/p aff\h

p (M ef wjw (q i INioterox October 16,1997 Mr. Steven Baggett US Nuclear Regulatory Commission Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards.

11555 Rockville Pike Rockville, MD 20852 Mail Stop T8F5 Re.: Registry update

Dear Mr,

Baggett, With this letter we ask that the NRC registry of the Metorex inc. manufactured / distributed devices is amended as specified point by point below.

The registries-affected are: NR 701-D 101 B, NR 701-D 102-B, and NR-701-D 103-B. -

Affected licenses are: 29-30342-01 and 29-30342-02G.

1. Please correct on the first page of each registry the address of d.istributor. This position

~ '

should read as fo!!ows:

Metorex Incorporated (formerly Outokumpu Electronics, Inc.)

Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618 n

Our comr m moved to the above mentioned location in January of 1997. We have applied for ameno,, ant to our licenses to reflect the change of location and have received amen licenses on May 23,1_997. We had an understanding that this change has been made to all

j e e,'

documents in the systemc l p ~ .._. _ _ _. _ ___

2. On page 6 of the Registry # NR-701-D 101-B add an Fe-55 (Iron-55) isotope source in the d t first table as follows: ~"

/h'i,d #

- in the last column titled " Isotope Products", in the first row, for Iron-55 isotope add (f A3895-1 and A3895 2; METOREx INC, Princeton crossroads corporate center Telephone Te4efox

_ Gn mn3m# %/ . I'. o. Box 3540 1 604406 9000 1-604 830 9055

'W "C'W V '7 y nne New Je 08543 1540

_ .__..___.______ _ _ _ _ _ _ - __.____m.__._.- _

", , e( ~

i% u This isotope capsule has been approved in the State of California, and is registered under registry # CA406S166S, dated 02-03 1997, the copy of which is enclosed as Attachment 1.- We have tested this source by installing it in Metorex devices, and measuring radioactive

' dose around them. In no instant the dose exceeded the value of 0.05mR/hr, when shutter of tested device was closed. The dose rates measured with this source wher, exposed were comparable to or below the dose rates obtained witn Amersham sources, ModelIEC. As a .

matter of fact, this source is a copy of the Amersham design. This annular sealed source is reported by its manufacturer to exceed the test requirements of the ANSI 77C44433.

Therefore, on page 7 of the registry, in paragraph " Prototype Testing", plecte add this IPL Model numbers A38951, and A3895 2, with ANSI Rating of 77C44433. i

___ ~

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3. Please bdio the R$istry #NR 701 Df101'-B nevideVido7Model SIPS Probe) This is a new c gc/

device, which etilizes new, silicon p-i-n diode, room temperatufe f 55, Cd-109, and Am 241. The description of this new proba, its construction details and II the results of test measurements of radiation dose around it are enclosed as Attechment 2.

- Also enclosed is a copy of a Finnish Radiation Safety Review Report pertaining to this probe.

In the past, our registry was reviewed and updated by Mr. Douglas A. Broaddus, We would greatly apareciate if Mr. Broaddus could also work )n the current applics . ion ac this most certainly would speed up the review process.

The copy of this letter is being forwarded to the Licensing Section of NRC Region I, King of Prussia, along with the request for appropriate license amendment.

Enclosed with this letter is also a cheque for $ 610.00 to cover the review fee.

Should you have any questions, please call me at 609-406-9000 ext.105, or fax at 609-530-0842. My e-mail is StanPrex@aol.com.

Yours sincerely, n )

Stanislaw Pioreki Ph.D.

Radiation Safety Officer and V. President, Research and Product Development Encl.: - copy of the IPL Registry, #CA406S166S

- technical data and radiation dose measu ements for Model SIPS probe.

- copy of the Finnish Authorities Test Certificate for Model SIPS probe.

- cheque #21435, for the amount of $ 610.00.

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PAGE1 NRC FORM 567 U. S. NUCLEAR REOULATORY COMMISSION l'fC-REQUEST FOR A SEALED SOURCE OR 'g y DEVICE EVALUATION e :._-a G.-w "

WSTRUCTIONS: Send true request AND e copy of en reisted e end drowings to: The Sealed Source safety Secmon ATTN; Chsef.

OWFN Mel Stop 6 H3 Change the Ucense Trecedrg System rnaleatone to 19 and seeign to rwiewer code l-5.

NOTE: Rotein a copy of this request with the apf*aHM and tieckground flee.

g RecuEstER REGION / LOCATION:

/ M ,__ ,d . lI C ll C lil IV RV R HQ R LFDCL

] TELEPHODE NUMeER ~ DATE' TYPE OF ACM REQWSTED $lieck as L, , ^

t Amcure pwaE . SOURCE REVIEW AMENDMENT OF 2

imL cOwmOL NUMeERm J [/42vA DEVICE REVIEW REGI BE LETTER /APPUCATION DATE UCENoE NUMeERm CUSTOM REVIEW - Nbh/@ d i o/t &/9 *7

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90 pw A 6ersu m (%ywah W fo & as>m A%>no , w %s my.g- as se FOR SSSsuSE OfCf MODEL NUMeERS NUteER AmeIODED REVIEWER ~

$0Ws e*A /0 DATE A$eGNED DATE TO FEES DATE RECErVED

/O ,2o [7 / 2h, y i

/ TYPE OF ACnON orute,*.wie nunesi or.nen type >

l USE BY A SINGLE APPUCANT (CUSTOM)

JCOt4AERCIAL DISTRIBUTION (FORMAL)

DEVICE (9A) SOURCE (90) DEVICE (98)

, SOURCE (9C)

NEW NEW NEW ENDMENT AMENDMENT AMENDMENT AMENDMENT _v _ _

MNO SAFETY EVALUATION REQU: RED j UCENSING ACTION REQUIRED IF KNOWN -

< NO FEES REQUIRED NO j OTHER (Spedy)

TOTAL NUMBER OF NOTES fA$

DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR SILs.ING PURPOSES Of4.Y j NEW REGISTRATION - J PRODUCTINACTIVE -

NAME CHANGE ADDRESS CHANGE REMOVE . ROM BILUNG ADD TO BILLING FOR FEE USE OSS Y TYPE OF FEE FEE CATEGORY khh 2M UM E bE

/ CHECK NUMoER MATANN UPDATED RECE O i

% (,{% q_ _

AS REQUIRED

^~'" N% % fla D 04- 9 J' M J Z'e'o*u=o^"

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