Intracranial haematoma detector

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Tersedia dari:

TBI diagnostics Pty Ltd

Kelas:

Class IIa

Diproduksi oleh:

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

Area terapi:

62661 - Intracranial haematoma detector

Indikasi Terapi:

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.

Status otorisasi:

A

Tanggal Otorisasi:

2019-08-13