Endoscopic

Main information

  • Trade name:
  • Endoscopic video image processor
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Endoscopic video image processor
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221506
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221506

Pentax Medical Pte Ltd - Endoscopic video image processor

ARTG entry for

Medical Device Included Class 1

Sponsor

Pentax Medical Pte Ltd

Postal Address

Unit 203 / 15 Orion Road,Lane Cove, NSW, 2066

Australia

ARTG Start Date

20/03/2014

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

Hoya Corporation

2-7-5 Naka-Ochiai

Shinjuku-ku, Tokyo, 161-8525

Japan

Products

1. Endoscopic video image processor

Product Type

Medical device system

Effective date

20/03/2014

GMDN

18034 Endoscopic video image processor

Intended purpose

This electro-medical equipment (Video Processor) is intended to be used for endoscopic diagnosis and

treatment.

Together, this Video Processor and PENTAX video endoscope may provide optical visualization of, and/or

therapeutic access to, various body cavities, organs and canals.

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 12:50:20 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

7-5-2018

FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

FDA - U.S. Food and Drug Administration

There are no news related to this product.