Summary for ARTG Entry:
Carl Zeiss Pty Ltd - Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator
ARTG entry for
Medical Device Included Class IIa
Carl Zeiss Pty Ltd
PO Box 501,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
Jena, , D-07745
1. Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator
Single Device Product
59682 Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator
The Flat Applicator is intended to supply a specified radiation dose during applications exclusively in
combination with the INTRABEAM System during intraoperative radiotherapy on a surgically exposed
surface or in a tumor bed, or during treatment of tumors on the body surface.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:31:18 AEDT
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