IGI

Primary DI
07290016855005
Brand
IGI
Company
IMAGE NAVIGATION LTD
Model
A-IG-0005
Catalog number
A-IG-0005
Device description
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).
Published
2017-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023424000
K052840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023424000IGI-SYSTEMDenx Advanced Dental Systems2003-05-09HAW
K052840000IGI-SYSTEMDenx Advanced Dental Systems2005-12-16HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016855005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016855005072900168550057290016855005

GMDN Terms#

Term, Definition table
TermDefinition
Dental stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97226417748info@image-navigation.com

Regulatory Flags#

DUNS number
532112401
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016855012IGIA-IG-0005-V1.5A-IG-0005-V1.52020-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless SteelMEDTRONIC NAVIGATION, INC.HAW2026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KITMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer TrackerMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification DeviceMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25