Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Linear Array Transducer, Type 8809 - Transducer assembly, ultrasound,
diagnostic, intracorporeal, surgical
ARTG entry for
Medical Device Included Class III
Paragon Healthcare Pty Ltd
1 / 56 Norcal Road,NUNAWADING, VIC, 3131
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.
B-K Medical ApS
Herlev, , 2730
1. Linear Array Transducer, Type 8809 - Transducer assembly, ultrasound, diagnostic, intracorporeal,
Single Device Product
40770 Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
A hand-held ultrasound transducer assembly designed to be positioned within a surgical site for localized
intra-operative imaging applications. It steers, focuses, and detects the ultrasound beam and resulting
echoes electronically. This device is reusable.
Linear Array Transducer Type 8809 is an intraoperative ultrasound transducer suitable for vascular and
musculoskeletal applications. It steers, focuses, and detects the ultrasound beam and resulting echoes
electronically. This device is reusable
Nil variant (as 1 device) No Variant
No Specific Conditions included on Record
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