Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Innovative Medical Pty Ltd - Intracranial haematoma detector
ARTG entry for
Medical Device Included Class IIa
Innovative Medical Pty Ltd
3 Oak Court,Somerville, VIC, 3912
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.
3508 Market Street
Philadelphia, PA, 19104
United States Of America
1. Intracranial haematoma detector
Single Device Product
62661 Intracranial haematoma detector
Intracranial haematoma detector, Infrascanner is intended to be used for the detection of traumatic
supratentorial haematomas of greater than 3.5 mL in volume that are less than 2.5 cm from the brain
surface, as an adjunctive device to the clinical evaluation in the acute hospital setting of adult and
paediatric patients with suspected traumatic supratentorial intracranial haematoma.
The Infrascanner is indicated to assess patients for CT scans but should not serve as a substitute for
these scans, and to be used by physicians, or under the direction of a physician, who has been trained in
the use of the device.
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Produced at 02.11.2019 at 07:04:46 AEDT
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