IGI - The Image-Guided Implantation system is an - IMAGE NAVIGATION LTD

Duns Number:532112401

Device Description: The Image-Guided Implantation system is an image-guided surgery system, designed to provid The Image-Guided Implantation system is an image-guided surgery system, designed to provide guidance of surgical instruments used in dental implantation procedures. The system implements the well-established advances in the fields of computer-aided surgery and image-guided surgery into the field of dental implantology. The IGI-system provides accurate guidance of the surgical instruments with regard to the patient’s anatomical structures and to the pre-surgical plan, based on the patient’s CT imaging.The system is an infra-red optics-based navigational system, which utilizes an infra-red camera sensor and light-emitting diodes (LEDs) to monitor objects in a defined space. The system comprises of the following components: computer processing unit, monitor, tracking camera and trackable appliances (designed to monitor the surgical hand-piece and patient position).

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More Product Details

Catalog Number

A-IG-0005

Brand Name

IGI

Version/Model Number

A-IG-0005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K023424,K052840

Product Code Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

a370d7e4-813f-4aac-9ddc-2441ca8bc359

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

April 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMAGE NAVIGATION LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2