Image

Main information

  • Trade name:
  • Image segmentation application software
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Image segmentation application software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220060
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220060

Smith & Nephew Pty Ltd - Image segmentation application software

ARTG entry for

Medical Device Included Class 1

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

12/02/2014

Product category

Medical Device Class 1

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

Smith & Nephew Inc Endoscopy Division

150 Minuteman Road

Andover, Massachusetts, 01810

United States Of America

Products

1. Image segmentation application software

Product Type

Single Device Product

Effective date

12/02/2014

GMDN

47502 Image segmentation application software

Intended purpose

The DYONICS PLAN software is intended for use as a software interface and image segmentation system

for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is

also intended as pre-operative or post-operative software for simulating/evaluating hip preservation

surgical treatment options and historical case review, respectively.

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 05:28:29 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

14-8-2018

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-10-2018

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995.

FDA - U.S. Food and Drug Administration