ML20198D338
| ML20198D338 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/1998 |
| From: | Compton E NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Demke T AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20138M147 | List: |
| References | |
| SSD, NUDOCS 9812230060 | |
| Download: ML20198D338 (2) | |
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UNITED STATES eo f.L j
NUCLEAR REGULATORY COMMISSION l
't WASHINGTON. D.C. 20555-0001 d
.....s February 23, 1998 Thomas A. Demke, D.D.S.
l GE Medical Systems l.
3000 N. Grandview Blvd., W-641 Waukesha, WI 53188
Dear Dr. Demke:
This letter is in response to your application dated March 28,1997 requesting registration of the Model 2180506 Attenuation Correction Transmission Scan Box. We are in the process of evaluating your request. However, in order to continue our evaluation, the following information is necessary:
1.
Please provide additionalinformation concernin; the prototype testing of the device.
Specifically, the testing must verify that the dev ce wiil remain operational woen subjected to conditions associated with normal use and handling and will maintain its containment integrity (e.g., no loss of byproduct nor significant loss of shielding) when subjected to likely accident conditions. Testing should address conditions associated with cycling, impact, and vibration.
2.
The mechanical source position indicator is described as being yellow when the source
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is exposed (page H20) and noted also on an engineering drawing (page B84). However, conflicting statements indicate this color is red (pages G7 and 115). Please confirm the correct color of the mechanicaHndicator when the source is exposed.
3.
The location of the mechanical indicator is near the back of the scan box such that an -
individual could be exposed while bending over the gantry or reaching across the beam looking for the location of the source. Therefore, please indicate what 9[9 procedures / measures are necessary or will be taken to ensure that an inadvertent p
exposure to the user is not likely to occur.
4.
You have submitted engineering drawings and documentation which are marked confidential and proprietary. In order for this information to be withheld from public disclosure, you need to identify which items are specifically proprietary and the reasons
. for which the claimed informatio,n should be withheld, by submitting an affidavit, in
//,e accordance with 10 CFR 2.790, addressing this information. Conversely, if you do not consider this information proprietary please so state.
N, e 5.
Please provide technical specifications for the epoxy (including degrading effects due to
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radiation), motor, and belts. Specific model number or manufacturer names are not necessary, but performance specifications for the products are needed.
l The 0.5 mm (0.02 in) aluminum strip mounted to the source covering as shown on page 6[.
i B49 is not described elsewhere in the application. Please describe the purpose of this j
strip.
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4 7.
Since the proposed source identification labeling (page D2) appears to be handwritten, please describe the assurances that the labeling will remain legible (i.e., no smudging or fading). In addition, it may be unclear looking at the label as to which number is the J
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model number and which is the serial number. Please resolve this ambiguity.
Furthermore, the proposed device labeling (page DS) needs to include the vendor's name (GE Medical Systems), and the model number should be the same as the one stated in your application (2180506).
8.
Please submit a copy of either DBA's Quality Control or Quality Assurance program.
Furthermore, describe the means (e.g., audits and frequency) GE will verify DBA will manufacture these devices in accordance with the provisions stated in the application.
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9.
How will the sensitivity of a hand held survey meter be able to detect contamination of Y
0.005 microcurie (185 Bq) of Gd-153?
10.
Clearly identify the services and maintenance that may be performed by the user.
Specifically address leak testing, installation / changing of the collimator assembly, j
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removal of the 2 mm (0.079 in) copper filter, and other maintenance procedures for
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operating the device (i.e., changing the LED's, or cleaning the unit). Please provide procedures for services that the user may perform.
11.
Emergency procedures were not mentioned in the user's manual. Please clearly identify j
these emergency procedures (i.e., performing an emergency stop) and confirm that they V
will be added to the user's manual.
i 12.
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application. In particular, a statement is made in the 510(k) application concerning new source installation using a g
Isotope Products Laboratories Model A-3402. This conflicts with use of the Dupont j
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i Merck Pharmaceuticals NES8423 source indicated in your application to NRC. In i
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p' addition, the red LED indicating source exposure, had been changed to yellow. Verify y/
notification of FDA of these changes and any other changes from those statements in your 510(k) application.
j Please provide the requested information as soon as possible. If you have any questions, please contact me at (301) 415-5799 or Mr. John Lubinski at (301) 415-7868.
Sincerely Eric ompton, Engineering Aide Sealed ource Safety Section Medical, Academic, and Commercial Use Safety Branch Division oiindustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards, Distribution:
IMNS r/f SSD 97-30 NE01 DOCUMENT NAME: C:\\WP\\ MISC \\GE.DEF Ta nceive a copy of this document, indicate in the boa: "C" =-Copy without attachment / enclosure "E" = Copy with attachment / enclosure
'N' = No copy OFFICE IMAB c_ IMABgg d
NAME ECompton fc JLubinski DATE 02/23/98 02/(3 /98 OFFICIAL RECORD COPY