Address:Neuendorfstr. 23b,Hennigsdorf Brandenburg,DE
Device Description : The Fiagon Navigation System is intended as an aid for precisely locating anatom The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Fiagon Navigation System is intended as an aid for precisely locating anatom The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomyThis also comprises of accessories 1) Extension cable instrument 2) Multi Instrument support3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US)
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : Accessory to Fiagon navigation systems. Device for registration.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : Accessory to Cube navigation systems. Device for registration.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product FlexPointer are product variants of a navigated pointer probe forima The product FlexPointer are product variants of a navigated pointer probe forimage guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products FlexPointer Cranial is a product variants of a navigatedpointer pr The products FlexPointer Cranial is a product variants of a navigatedpointer probe for image guided surgical proceduresThe instruments are accessories to the Fiagon Navigation system.The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identifiedrelative to a CT or MR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products RegistrationPointer is a navigated pointer probe for performing non The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guidedsurgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which isdesigned to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigationsystem produced by Fiagon GmbH.The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system usingelectromagnetic navigation.The Fiagon Navigation – Extended Instrument Set ENT is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENTsurgery can be identified relative to a CT or MR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product RegistrationPointer Cranial is a navigated pointer probe for perform The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for imageguided surgical procedures. The RegistrationPointert Cranial is designed to be used with the Fiagon Navigationsystem. The instrument is an accessory to the Fiagon Navigation system produced by fiagon GmbH.The instrument is accessories to the Fiagon Navigation system.The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identifiedrelative to a CT or MR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product FlexPointer 1.5 are product variants of a navigatedpointer probe fo The product FlexPointer 1.5 are product variants of a navigatedpointer probe for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products FlexPointer 1.5 Cranial is a product variant of a navigatedpoint The products FlexPointer 1.5 Cranial is a product variant of a navigatedpointer probe for image guided surgical proceduresThe instruments are accessories to the Fiagon Navigation system.The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identifiedrelative to a CT or MR based model of the anatomy.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes