Brainlab CranialENT System

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

BRAINLAB LIMITED (SINGAPORE BRANCH)

수업:

Class C medical device

Manufactured by:

Brainlab AG

치료 영역:

Neurology

치료 징후:

The Cranial/ENT system is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to a virtual computer image space on patient image data being processed by the IGS workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy

제품 요약:

Device System Info:[System or Procedure Pack], System with instruments and accessories; Models: REGISTR. MATRIX IMRI NORAS HEADHOLDER - 19102, ADHESIVE FLAT MARKER FOR SCANNER (10PCS) - 19144A, IGSONIC ADAPTER ARRAY (DRAPELINK) - 22595, ULTRASOUND REGISTRATION PHANTOM w/ HWUG - 22630A, ST. CRANIAL REF. ARRAY - 4 MARKER (1PC) - 41725, REFERENCE CLAMP UNIVERSAL (CRANIAL, 1PC) - 41734, INSTR. ADAPTER ARRAY (STARLINK), SIZE M - 41798, INSTR. ADAPTER ARRAY (STARLINK), SIZE ML - 41799, INSTR. ADAPTER ARRAY (STARLINK), SIZE L - 41801, INSTR. ADAPTER ARRAY (STARLINK), SIZE XL - 41802, INSTRUMENT CALIBRATION MATRIX (REV.4) - 41874B, HEADBAND REFERENCE STAR - 41877A, REFERENCE HEADBAND (10 PCS) - 41878E, VARIO REFERENCE ARM - 52001F, SKULL REFERENCE ARRAY (STAR) - 52122A, SKULL REFERENCE ARRAY (BASE) - 52129B, INSTR. ADP OFFSET-LINK 45° 20MM STARLINK - 55013, MULTIPLE-TIP-POINTER SHAFT STARLINK - 55791A, MICROSCOPE UNIVERSAL TRACKING ARRAY - 41767-19A, MICROSCOPE ADAPTER ZEISS - 41767-55B, MICROSCOPE ADAPTER LEICA - 41767-70C, MICROSCOPE ADAPTER HS/MOELLER - 41767-85, US NAV ADAPTER BASE(BK 8862/8863/N11C5s) - 41860-35B, IGSONIC ADAPTER BASE FOR ALOKA UST-9120 - 41860-5D, HEADBAND REFERENCE STAR - CONNECTOR - 41877-10, SUCTION STD (CH 8) STARLINK - 55790-05A, SUCTION FS L (CH 8) STARLINK FRAZIER - 55790-15, SUCTION FS R (CH 8) STARLINK FRAZIER - 55790-25, SUCTION MS (CH 8) STARLINK FRAZIER - 55790-55, SUCTION MS (CH 10) STARLINK FRAZIER - 55790-65, SUCTION STD (CH 10) STARLINK FRAZIER - 55790-70, SUCTION STD (CH 8) STARLINK FRAZIER - 55790-75, MULTI-MODALITY FIDUCIAL MARKER (100 PCS) - 52160, Eraser Pointer Tip (Curved) - 55791-06, Eraser Pointer Tip (Straight) - 55791-07, Z-TOUCH POINTER - 18370, KICK NAVIGATION STATION - 18070, CURVE DUAL DISPLAY NAVIGATION STATION - 19900, CURVE 1.1 DUAL NAVIGATION STATION - 19901, PATIENT SCAN DRAPE (10 PCS) - 22182, CRANIAL REFERENCE UNIT DRAPELINK - 19152, ADAPTER KIT FOR DRAPELINK - 19153, Sterilization Tray ENT/CMF - 52311, Sterilization tray Standard Cranial Accessories - 52315, Sterilization Tray Cranial - 52305, Sterilization Tray VarioGuide - 52303, CRANIAL REFERENCE ARRAY DRAPELINK - 19152-02, INTERCONNECTOR DRAPELINK - 19152-01, DRAPELINK INTERFACE iCT CALIBRATION PHANTOM - 19142-06, ADAPTER FOR MAYFIELD SKULL CLAMP - 19153-01, ADAPTER FOR DORO SKULL CLAMP - 19153-02, BASE LONG FOR DRAPELINK - 19153-03, BASE SHORT FOR DRAPELINK - 19153-04, EM Disposable Stylet - 18097, EM Patient Reference - 18099-24, EM Registration Pointer - 18099-23, EM SKULL REFERENCE BASE - 18099-06, Cranial EM - 04056481132422, EM Pointer - 18099-02C, Instrument Adapter EM - 18099-05A, Curve 1.2 - 19901B, Cranial IGS System Automatic Registration iMRI 1.0 (1.0.0) - 04056481141127, Cranial IGS System Ultrasound Navigation 1.1 (1.1.0) - 04056481142650, Microscope Navigation 1.6 (1.6.0) - 04056481142537, Cranial Navigation System Registration 3.5 (3.5.1) - 04056481140687, Cranial Navigation System Navigation 4.0 (4.0.0) - 04056481141356, Z-TOUCH REV2 - 18370-10, SOFTOUCH POINTER (REV3) - 18390-10A, SOFTOUCH POINTER (REV3) GAUGE - 18390-40A, REGISTR. MATRIX IMRI GE HEADHOLDER - 19202C, AUTOMATIC REGISTRATION MATRIX iMRI - 19208-01, REF ADAPTER DRAPELINK FOR AUTOM REG iMRI - 19208-02, POINTER, BLUNT TIP - 41780-5G, US NAV ADAPTER BASE (BK N13C5) - 41860-40, ULTRASOUND ADAPTER SONOSITE HFL38X - 41860-42, US NAVIGATION ADAPTER BASE (BK X18L5s) - 41860-43, V-INSET-MAYFIELD KIT - 52003, V-INSET-IMRIS KIT - 52005, V-INSET GE HEADHOLDER KIT - 52006, INSTRUMENT ADAPTER EXTENSION 50 MM - 55016, INSTR ADAPTER CLAMP (STARLINK), SIZE S - 55101, INSTR ADAPTER CLAMP (STARLINK), SIZE L - 55103, ADAPTER FOR RECTANGULAR INSTRUMENTS - 55105, ADAPTER FOR CYLINDRICAL INSTRUMENTS - 55110, INSTR ADAPTER CLAMP SIZE L (SOFTGRIP) - 55113, INSTR ADAPTER CLAMP SIZE XL (SOFTGRIP) - 55114, POINTER TIP (OFFSET 0°, LENGTH 150 MM9 - 55791-01, POINTER TIP (OFFSET 30°, LENGTH 95 MM) - 55791-03, POINTER TIP (OFFSET 0°, LENGTH 100 MM) - 55791-04, POINTER TIP (OFFSET 0°, LENGTH 60 MM) - 55791-05, POINTER TIP STRAIGHT BLUNT (D3.4MM) - 55791-34, VARIOGUIDE ARRAY - 55950-40B, VARIOGUIDE HARDWARE (VERSION G) - 55950-70G, MICROSCOPE INTEGRATION KIT LEICA - 41767-04C, SUCTION MS (CH 8) STARLINK - 55790-50A, DISPOS: BIOPSY NEEDLE KIT (5 PCS.) 1.8MM - 41779C, DISPOSABLE STYLET (10 PCS) - 55797, Cranial/ENT 3.1.5 DBF177 - 04056481132439

승인 날짜:

2015-10-15