Probe

Main information

  • Trade name:
  • Probe, measuring instrument, radiation, solid-state semiconductor
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Probe, measuring instrument, radiation, solid-state semiconductor
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221605
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221605

alphaXRT Pty Ltd - Probe, measuring instrument, radiation, solid-state semiconductor

ARTG entry for

Medical Device Included Class IIb

Sponsor

alphaXRT Pty Ltd

Postal Address

Suite 1-15 / Level 1 / 90-96 Bourke Road,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

24/03/2014

Product category

Medical Device Class IIb

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

Sun Nuclear Corp

3275 Suntree Boulevard

Melbourne, FL, 32940

United States Of America

Products

1. Probe, measuring instrument, radiation, solid-state semiconductor

Product Type

Single Device Product

Effective date

24/03/2014

GMDN

38336 Probe, measuring instrument, radiation, solid-state semiconductor

Intended purpose

A device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor

serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument

used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity

and its energy discrimination properties allow it to be incorporated in radiation detection, measurement

instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor

material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray,

high-energy beta particles or neutrons) that can be detected.

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 12:31:55 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