ML18071A003
| ML18071A003 | |
| Person / Time | |
|---|---|
| Issue date: | 03/29/2018 |
| From: | Maria Arribas-Colon NRC/NMSS/DMSTR/MSLB |
| To: | London W GE Medical Systems, State of TX, Dept of State Health Services |
| Arribas-Colon M | |
| Shared Package | |
| ML17297A004 | List: |
| References | |
| 18-02, 7006, 7007 | |
| Download: ML18071A003 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 29, 2018
GE Medical Systems (Healthcare)
ATTN: Wayne London
Radiation Safety COE GE Global Operations - Environmental, Health and Safety 3000 North Grandview Blvd.
Waukesha, WI 53188
SUBJECT:
GE HEALTHCARE REGISTRATION CERTIFICATES NO. NR-1032-D-103-S AND NR-1032-D-104-S
Dear Mr. London:
This letter is in response to the State of Texas request dated October 5, 2017, requesting to transfer GE Healthcare Texas Sealed Source and Device Registrations Nos. TX-1032-D-103-S and TX-1032-S-104-S to U.S. Nuclear Regulatory Commission (NRC). We have issued new registration certificates NR-1032-D-103-S and NR-1032-D-104-S to replace TX-1032-D-103-S and TX-1032-S-104-B. Copies of the new registration certificates are enclosed.
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 your registration certificates. As a general rule, you must request and obtain an amendment to the certificates before you make changes or modifications to the information submitted to obtain the certificates.
Note that a certificate of registration, by itself, does not convey authorization for possession or distribution of radioactive sources or devices. An NRC or Agreement State license is required for possession and distribution of radioactive materials, sources, or devices.
Please read over the registration certificates in its entirety and notify us immediately of any errors or omissions.
GE Medical Systems (Healthcare) registration certificates will be subject to the NRC annual fee category 9A, which may be found under 10 CFR 171.16, "Annual fees: Materials licensees, holders of certificates of compliance, holders of sealed source and device registrations, holders
of quality assurance program approvals, and government agencies licensed by the NRC."
You are obligated to notify us promptly in writing should you decide to no longer manufacture, distribute, or offer service support for the product.
W. London 2
If you have any questions, please contact me at Maria.Arribas-Colon@nrc.gov or at (301) 415-6026.
Sincerely, /RA/
Maria Arribas-Colon, Project Manager Materials Safety Licensing Branch
Division of Materials Safety, Security, State, and Tribal Programs
Office of Nuclear Materials Safety and Safeguards
Enclosures:
- 1. Certificate NR-1032-D-103-S
- 2. Certificate NR-1032-D-104-S
ML18071A003 OFC NMSS/MSST/MSLB NMSS/MSST/MSLB NMSS/MSST/MSLB NAME MArribas-Colon THerrera MArribas-Colon DATE 3/29/2018 3/29/2018 3/29/2018