Summary for ARTG Entry:
GE Healthcare Australia Pty Ltd - Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held
ARTG entry for
Medical Device Included Class IIa
GE Healthcare Australia Pty Ltd
PO Box 5079,PARRAMATTA DC, NSW, 2150
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.
Humanscan Co Ltd
Room 301 303 319 320 Sihwa APT Factory
Jiwon-ro 107 Danwon-gu
Ansan-si, Gyeonggi-do, 425-836
Korea - Republic of
1. Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held
Single Device Product
40768 Extracorporeal ultrasound imaging system transducer, hand-held
This ultrasound transducer assembly is intended to be extracorporeal and includes single or multiple
element transducer assembly configurations that convert electric voltages into an ultrasound beam. It is
intended to be a held-hand device that moves from location to location on the intact surface of a patient's
body during ultrasound imaging applications.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:05:31 AEDT
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