Linear

Main information

  • Trade name:
  • Linear Array Transducer, Type 8809 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Linear Array Transducer, Type 8809 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216981
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216981

Paragon Healthcare Pty Ltd - Linear Array Transducer, Type 8809 - Transducer assembly, ultrasound,

diagnostic, intracorporeal, surgical

ARTG entry for

Medical Device Included Class III

Sponsor

Paragon Healthcare Pty Ltd

Postal Address

1 / 56 Norcal Road,NUNAWADING, VIC, 3131

Australia

ARTG Start Date

6/11/2013

Product category

Medical Device Class III

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

B-K Medical ApS

Mileparken 34

Herlev, , 2730

Denmark

Products

1. Linear Array Transducer, Type 8809 - Transducer assembly, ultrasound, diagnostic, intracorporeal,

surgical

Product Type

Single Device Product

Effective date

6/11/2013

GMDN

40770 Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical

Functional description

A hand-held ultrasound transducer assembly designed to be positioned within a surgical site for localized

intra-operative imaging applications. It steers, focuses, and detects the ultrasound beam and resulting

echoes electronically. This device is reusable.

Intended purpose

Linear Array Transducer Type 8809 is an intraoperative ultrasound transducer suitable for vascular and

musculoskeletal applications. It steers, focuses, and detects the ultrasound beam and resulting echoes

electronically. This device is reusable

Variant information

Nil variant (as 1 device) No Variant

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 03:42:32 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

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-9-2018

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

In some circumstances the tempered glass pane may break or shatter unexpectedly into small pieces and may pose laceration injuries to consumers.

Health Canada

There are no news related to this product.