Intracranial haematoma detector

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

TBI diagnostics Pty Ltd

class:

Class IIa

manufactured_by:

InfraScan Inc 3508 Market Street, Philadelphia, PA, 19104 United States Of America

therapeutic_area:

62661 - Intracranial haematoma detector

therapeutic_indication:

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.

authorization_status:

A

authorization_date:

2019-08-13