7D Surgical Cranial Image Guidance System - Stereotactic surgery system, multi-purpose

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Life Healthcare Pty Ltd

Class:

Class I

Manufactured by:

7D Surgical ULC 60 Scarsdale Road Unit 118, Toronto, ON, M3B 2R7 Canada

Therapeutic area:

45199 - Stereotactic surgery system, multi-purpose

Therapeutic indications:

The 7D Surgical System is a stereotaxic image guided surgical navigation system. The system provides image registration between pre-operatively acquired tomographic data and data captured intra-operatively from the Structured Light Imaging System. The system provides guidance data by displaying the locations of wireless optically tracked 7D Cranial Tracked Navigation Tools relative to the patient. Position and orientation data of the tracked tools are linked to the preoperative scan data using the system's onboard computer. The system is intended to be used as the primary surgical luminaire for image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

Authorization status:

A

Authorization date:

2019-03-08