Summary for ARTG Entry:
Carl Zeiss Pty Ltd - INTRABEAM Spherical Applicator - Intraoperative/postoperative therapeutic x-ray
system spherical applicator
ARTG entry for
Medical Device Included Class III
Carl Zeiss Pty Ltd
PO Box 501,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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. INTRABEAM Spherical Applicator - Intraoperative/postoperative therapeutic x-ray system spherical
Single Device Product
59681 Intraoperative/postoperative therapeutic x-ray system spherical applicator
The spherical spplicators are used in conjunction with the INTRABEAM system to deliver a prescribed
dose of radiation to the tumor bed or tumor margins during intracavity or intraoperative radiotherapy
The spherical spplicators are accessory items to the INTRABEAM system. They are used in conjunction
with the INTRABEAM system to deliver a prescribed dose of radiation to the tumor bed or tumor margins
during intracavity or intraoperative radiotherapy treatments.
Diameter (mm) 1.5cm to 5cm
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:30:30 AEDT
This is not an ARTG Certificate document.
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