Australia TGA ARTG recordIntracranial haematoma detector
Australia TGA ARTG Registered Device · TBI diagnostics Pty Ltd · InfraScan Inc · Class IIa · Started August 13, 2019
Good Name: TBI diagnostics Pty Ltd - Intracranial haematoma detector
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- August 13, 2019
- Effective Date
- August 13, 2019
- Name
- InfraScan Inc
- Country
- United States of America
- Address
- 3508 Market Street, Philadelphia, PA, 19104
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.
Access comprehensive regulatory information for Intracranial haematoma detector in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by TBI diagnostics Pty Ltd, manufactured by InfraScan Inc in United States of America. The device registration started on August 13, 2019.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.