Summary for ARTG Entry:
Whiteley Diagnostic Pty Ltd - ESAOTE MyLabSeven, MyLabAlpha,MyLabTwice - Ultrasound system,
ARTG entry for
Medical Device Included Class IIa
Whiteley Diagnostic Pty Ltd
PO Box 5137,ELANORA HEIGHTS, NSW, 2101
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.
Via Siffredi 58
, Genova, 16153
1. ESAOTE MyLabSeven, MyLabAlpha,MyLabTwice - Ultrasound system, imaging, general-purpose
Medical device system
40761 Ultrasound system, imaging, general-purpose
A general-purpose diagnostic ultrasound imaging system designed exclusively for use in a wide variety of
both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. A
general-purpose system supports a wide variety of transducers and related application software packages
allowing for the collection, display and analysis of ultrasound information. Usages are, e.g.
general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler
or colour Doppler, depending on the operating system specific software packages and compatible
No Specific Conditions included on Record
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Produced at 09.11.2017 at 10:46:38 AEDT
This is not an ARTG Certificate document.
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