Operator

Main information

  • Trade name:
  • Operator console, x-ray system, diagnostic
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Operator console, x-ray system, diagnostic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221196
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221196

Hologic Australia Pty Ltd - Operator console, x-ray system, diagnostic

ARTG entry for

Medical Device Included Class IIb

Sponsor

Hologic Australia Pty Ltd

Postal Address

PO Box 1971,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

12/03/2014

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

Hologic Inc

250 Campus Drive

Marlborough, MA, 01752

United States Of America

Products

1. Operator console, x-ray system, diagnostic

Product Type

Single Device Product

Effective date

12/03/2014

GMDN

40968 Operator console, x-ray system, diagnostic

Intended purpose

This operator console contains the primary controls for the direct operation of the ATEC breast biopsy

system. The free standing console and system provide the ability to biopsy and excise in any of the three

primary diagnostic imaging modalities of stereotactic x-ray, ultrasound and MRI.

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 02.12.2017 at 05:28:54 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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