Radiation

Main information

  • Trade name:
  • Radiation therapy treatment planning system, application program software
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Radiation therapy treatment planning system, application program software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221419
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221419

alphaXRT Pty Ltd - Radiation therapy treatment planning system, application program software

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

18/03/2014

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

LifeLine Software Inc

3304 South Broadway Avenue Suite 200

Tyler, TX, 75701

United States Of America

Products

1. Radiation therapy treatment planning system, application program software

Product Type

Medical device system

Effective date

18/03/2014

GMDN

40887 Radiation therapy treatment planning system, application program software

Intended purpose

An individual software program or group of programs, routines or algorithms that add specific computer

assisted display, processing and/or analysis capabilities to a radiation therapy treatment planning system

configuration. A basic set of applications programs and routines are included with such computer

controlled therapy systems and they can be upgraded to correct programming errors or to add new system

capabilities. Some must be combined with specific hardware or firmware accessories or configurations in

order to function as intended. Applications program packages are typically identified by a proprietary name

and "version" or "upgrade" number.

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 01:08:19 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

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

28-9-2018

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA - U.S. Food and Drug Administration

8-1-2018

Dose Matters: FDA's Guidance on Children's X-rays

Dose Matters: FDA's Guidance on Children's X-rays

FDA is committed to protecting the health of children by helping lower their exposure to radiation from X-ray exams.

FDA - U.S. Food and Drug Administration

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

14-9-2018

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgDd 

FDA - U.S. Food and Drug Administration

25-5-2018

Today is #DontFryFriday. Stay informed about skin safety. Check out the FDA’s information on UV radiation and tanning devices  https://go.usa.gov/xQyEz pic.twitter.com/z6OFXyYitD

Today is #DontFryFriday. Stay informed about skin safety. Check out the FDA’s information on UV radiation and tanning devices https://go.usa.gov/xQyEz pic.twitter.com/z6OFXyYitD

Today is #DontFryFriday. Stay informed about skin safety. Check out the FDA’s information on UV radiation and tanning devices https://go.usa.gov/xQyEz  pic.twitter.com/z6OFXyYitD

FDA - U.S. Food and Drug Administration

17-5-2018

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration