ML20202J342
| ML20202J342 | |
| Person / Time | |
|---|---|
| Issue date: | 02/18/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Piorek S AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9802230136 | |
| Download: ML20202J342 (1) | |
Text
February 18, 1998 Dr. Stanislaw Piorek, President Motorex, Inc.
Princeton Crossroads Corporate Center j
250 Phillirs Boulevard Ewing, NJ OG618
Dear Dr. Piorek,
Based en the information submitted in your application dated October 16,1997, we have changed the distributor's address for Registration Certificate Nos. NR 701 D 101 B, NR 701 D-102 B, and NR 701 D-103 B. Please find the front pages, showing the new address, in the Enclosure for you to attach to the certificates. We will address your other requests for adding the use of additional sources and another device to Registration Certificate No. 701 D 101 B in separate correspondance.
i Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in l
your registration certificates. As a general rule, you must request and obtain an amendment to the l
certificate before you make changer or modifications to the information submitted to obtain the certificato.
I; lease read over the registration certificates in their entirety bad notify us immediately if there are any errors or omissions.
Please be aware that, as a holder of an NRC iegistration certificate, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171.
If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
if you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at (301) 415 7273.
Sincerely, original signed by John P. Jankovich, Ph.D., Sr. Engineer Sealed Source Safety Section Medical, Academic, and Commercial Uae Safety Branch Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l
Enclosure:
As stated I
cc w/ encl: SKimberley, LFDCB Distribution:
IMNSr/f SSD 97-04 SSD 97-65 NE01 SSD File # NR 701 D-101 B SSD File # NR 701 D-102 B SSD File # NR 701-D iO3 B DOCUMENT NAME:
t.
- w....n i tw. e nt. mac.i. in m. b.o c - copy wim ui.es. chm.nt/.ncio.u. t copy witn.it.e%m nti.ncio.ur.
=
u..opy OFFICE IMNS jpt l6 IMNSf/)
F l
NAME JJaigovicy i(
SBagg'ett DATE 02/l//98 '
02/ }/98 i
OFFICIAL RECORD COPY lll ll l l
$22 136 980218 SSD PDR
9'd own. t 7
}
es October 16,1997 i
Mr. Steven Baggett US Nuclear Regulatory Commission Sealed Source Safety Section t
Source Containment I
and Devices Branch i
Division of Industrial and Medict!
Nuclear Safety, _
Office of Nuclear Material Safety and Safeguards.
11555 Rockville Pike Rockville, MD 20852 Mail Stop T8F5 l'.e.: Registry update
Dear Mr. Baggett,
With this letter we ask that the NRO registry of the Metorex Inc, manufactured / distributed devices is a, mended as specified point bypoint below.
The registries affected are: NR 701 D 1018, 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 distributor. This position should read as follows:
Metorex incorporated (formerly Outokumpu Electronics, Inc.)
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618 Our company moved to the above mentioned location in January of 1997. We have appil.ed OL for amendment to our licenses to reflect ths change of location and have received amended (3 licenses on May 23,Uem.11997. We had an understanding that this change has been mad
- bc e
d66urhent's7n'th~5~ sy p _. - - _
- 2. On page 6 of the Registry # NR 701 D 101 B add an Fe 55 (Iron 55) isotope souri:e in the (t n
,/j d.
first table as follows:
^"
~
,P
~
in the last column titled " Isotope Products", in the first row, for Iron 55 isotope add
(
A38951 and A3895 2; METOREX INc, Princeton crossroade Comorou Center Telephene Telefes f
P. O. Som 3640 1 604406 9000 1609 '30 90$$
~q W r
enne.,on. ne. >,06uuuo k o u L a^ty LW' Twv
4 This isotope capsula has been approved in the State of California, and is registered under registry # CA406S',66S, dated 02 03 1997, the copy of which is enclosed as Attachment i
- 1. We have tested 'this source by installing it in Metorex devices, and measuring radioactive i
dose around them, in no instant the dose exceeded the value of 0.05mR/hr, when shutter of tested device wris closed. The dose rates measured with this source when exposed were cornparable to or telow the dose rates obtained with Amersham sources, Model IEC. As a matter of fact, thira source is a copy of the Amersham design. This annular sealed source is reported by its manufacturcr to exceed the test requirements of the ANSI 77C44433.
Therefore, on page 7 of the registry, in paragraph " Prototype Testing *, please add this IPL Model numbers A38951, and A3895 2, with ANSI Rating of 77C44433.
,[
- 3. Please [dd
._,f._to the Registry #NR 701 D 10 B.new device;Model SIP 5' Probe)T device, which utilizes new, silicon p i n diode, room temperature detecto
~
( th 55, Cd 109, and Am 241.
The description of this new probe, its cor'struction details and v 1
the results of test measurements of radiation dose around it are enclosed as Attschment 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 apareciato if M'. Broaddus could also work >n the current application as this most certainly would speed up the review process.
I The cupy of this letter si being forwarded to the Licensing Section of NRC Region I, King of Prussia, along with the rsquest 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,
&2
.a Stanislaw Piorek, Ph.D.
Radiation Safety Officer and V. President, Research and Product Development Encl.: - copy of the IPL Registry, #CA406S166S technical data and radiation dnse measurements for Model SIPS probe, copy of the Finnish Authorities Test Certificate for Model SIPS probe.
cheque #21435, for the amount of 6 610.00.
October 31,1997 ASSIGNMENT NUMBER: 97 64,97 65,97 66 Dr. Stanislaw Piorek Metorex, Inc.
Princean Crossroads Corporate Center P.O. Box 3540 Prir.;eton, NJ 08543 3540
SUBJECT:
ACKNOWLEDGEMENT OF REQUEST F-OR SAFETY EVALUATION
Dear Dr. Piorek:
Thi:, 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 review of your application and determined that enough information has been provided to allow a technical re tiewer to initiate the evaluation mocess. Appl: cations are assigned ti technical reviewers on e first in basis. Therefore, your application will be assigned in turn. Please note that the techriical 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) 415-8140.
Please reference the assignment nurriber 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. Theefore, a copy of your application has been forwarded to the License Fee and Debt Collection Bianch for approval of the feo category and amount, if you have any questions concerning the fees associated with your application, please contac% License Fee and Debt Collection Branch at (301) 415-7554.
Sincerely, iH KimBerly Randall, Registration Assistent Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division ofindustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
SSSS r/f SSD 97 64 97 659 SBaggett NE01 97-66 DOCUMENT NAME:P;97 64 66.wpd n m.
,.e ne nt. me... m m. w c - c,, inout.ti.cr ni/.nei ur.
- c.,,
th ti.en ni/.nci..ur.
u - we c,y OFFICE IMAB l
l l
- l NAME KRandal)W DATE 10// /07 f
OFFICIAL RECORD COPY S
p n q tIA%3
l REGISTRY Of RADIOACTIVE.3EALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Corrected page: address change only, February 17, 1998)
L: NR-0701-D-102-B DATE: September 29, 1995 PAGE 1 OF 7 DEVICE TYPE:
X-Ray Fluorescence Analyzer MODEL:
Courier 10 l
l DISTRIBUTOR:
Metorex Incorporated l
(formerly Outokumpu Electronics, Inc.)
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618 MANUFACTURER:
Metorex International, Oy (Formerly Outokumpu Instruments)
P.O.
Box 85 SF-02201 Espoo, Finland SEALED SOURCE MODEL DESIGNATION:
Amersham: ANC.D2, CUC.D1, CLCL, IEC.Al ISOTOPE:
M8)(IMUM ACTIVITY:
Americium-241 30 mci (1.11 GBq), \\AMC.D2)
Cadmium-109 20 mci (0.74 GBq), (CUC.D1)
Curium-244 100 mci (3.70 GBq), (CLCL)
Iron-55 80 mci (2.96 GBq), (IEC.A1)
LEAK TEST FREOUENCY:
6 montle.1 PRINCIPAL USE:
(U) X-Ray Fluorescence CUSTOM DEVICE:
YES X
NO Y
._m n,
PAGE1 NHC FORM 5C7 U, S. NUCLEAR REQULATORY COMMIS810N lf' REQUEST FOR A SEALED SOURCE OR pp-DEVICE EVALUATION G. c m, "/
DetTRUCTIONS: Send tNo request AND e copy of as reisted letters /opplicatione end drawings to: The Geeled Source Sofety SecrJon, A1TN: Ch'ef, OWFN Mel Stop 6 H3. Change the uoenee Tracidng System rnneetone to 19 and seeip. s reviewer code B-5.
NOTE: Rotein a copy of tNo requoet with the appacetion and bec4 ground files.
l RE u s1LR REGIOH/ LOCATION:
/
O//,
M.
li 11 R lil C IV MV C HQ C LFDCB 4
'nt>*oa NuuoER ~
DAff TYPE OF ACTION REQUESTED (Check es appropr' ate) i AOURCE REVIEW AMENDMENT 0:
uvucAwr8 NAM [Eg gjg REG ST lol. LHEET hwt CowmOL NWWER(5)
DEVICE REVIEW tritERwetcAfiON DATE UCENSE NUMOLR(S)
CUSTOM REVIEW Mb N"h/@ -S
/Yh Y
y 6 u.u r 6,.w< w w d o p uu< s & M <
" ~ ' * "
- L % asvo ALn,u, w %v as ys-3
- run FOR SSSE'USE OPOf REvDVLR MOOG NUMeERS NUMeER ASeOED 0 0(ds 'r*/
/0 oArE RECEMD DATE A$eONED DA1110 FEES
/
TYPE OF ACnON pnecate the nunber d each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPUCANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
NEW N
NEW NEW AMENDMENT u-ENDMENT AMENDMENT AMENDMENT
}
MNO SAFETY EVALUATION REQUIRED j UCENhNG *.CTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Spedy)
TOTAL NUMBER OF NOTES REVIEW HOURS gg g
NUMBER OF v
DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR SILLMG PURPOSES Opt.Y j NEW REGISTRATION -
_j PRODUCT INACTIVE -
J AME CHANGE ADDRESS CHANGE N
ADD TO BILUNG REMOVE FROM BILUNG FOR FEE USE Ope.Y -
TYPE OF FEE FEE CATEGORY khh EM OM M
M RECEWED
/ CHEW NUWeER y
MATANN UPDATED
~~
Mh
% q_
AS REQUIRED
% bc buu;,p ~ 0 4 r; 7 M MREQUYREo
~
- '* ""^ "
ibUuMO O/3B/s7
"~"
O