Intracranial haematoma detector

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
TBI diagnostics Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
321700

Public Summary

Summary for ARTG Entry:

321700

Innovative Medical Pty Ltd - Intracranial haematoma detector

ARTG entry for

Medical Device Included Class IIa

Sponsor

Innovative Medical Pty Ltd

Postal Address

3 Oak Court,Somerville, VIC, 3912

Australia

ARTG Start Date

13/08/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

InfraScan Inc

3508 Market Street

Philadelphia, PA, 19104

United States Of America

Products

1. Intracranial haematoma detector

Product Type

Single Device Product

Effective date

13/08/2019

GMDN

62661 Intracranial haematoma detector

Intended purpose

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.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 07:04:46 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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