PINPOINT

Main information

  • Trade name:
  • PINPOINT Endoscopic Fluorescence Imaging System - Endoscopic video imaging system
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • PINPOINT Endoscopic Fluorescence Imaging System - Endoscopic video imaging system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221822
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221822

Surgicore Pty Ltd - PINPOINT Endoscopic Fluorescence Imaging System - Endoscopic video imaging

system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Surgicore Pty Ltd

Postal Address

35 / 45-51 Huntley Street,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

31/03/2014

Product category

Medical Device Class IIa

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

Novadaq Technologies Inc

13155 Delf Place Unit 250

Richmond, British Columbia, V6V 2A2

Canada

Products

1. PINPOINT Endoscopic Fluorescence Imaging System - Endoscopic video imaging system

Product Type

Medical device system

Effective date

31/03/2014

GMDN

35616 Endoscopic video imaging system

Intended purpose

Pinpoint Endoscopic Fluorescence Imaging System is intended to provide real-time laparoscopic visible

and near infrared fluorescence imaging. Pinpoint enables surgeons to

perform routine visible light laparoscopic procedures as well as further visually assess circulation including

blood flow in vessels and microvessels, tissue and organ perfusion, and lymphatics and perfusion

associated with tumors and tumor margins with near infrared fluorescence imaging during minimally

invasive surgery.

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 09.11.2017 at 11:42:13 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