BrainLAB Cranial IGS 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:

Radiology / Imaging

치료 징후:

is a software system intended to be an intraoperative 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 computer 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], [Sterile Medical Device], System with accessories Sterile components sterilized by EO; Models: IPLAN CRANIAL SOFTWARE - 21200, IPLAN BOLD MRI MAPPING SOFTWARE - 21208, IPLAN STEREOTAXY SOFTWARE - 21210, IPLAN FLOW, LICENSE FOR 1 PATIENT USE - 21212, IPLAN AUTOMATIC IMAGE FUSION - 21230, IPLAN STEREOTAXY - ADDITIONAL GEOMETRY SUPPORT - 21241, IPLAN FUNCTIONAL SOFTWARE (AC/PC PLANNING & BRAINATLAS) - 21242, IPLAN CRANIAL AUTOMATIC SEGMENTATION SOFTWARE - 21251, IPLAN FIBERTRACKING SOFTWARE - 21257, Z-TOUCH CT/MR DATA REGISTRATION SOFTWARE - 21801, SOFTOUCH CT/MR DATA-REGISTRATION SOFTWARE - 21803, VARIOGUIDE ALIGNMENT WIZARD SOFTWARE - 21900, ERASER SOFTWARE - LIVE ANATOMY UPDATE - 22005, IMAGE COMPOSER SOFTWARE - 22010, SECOND DATA SET IMPORT FOR CRANIAL ESSENTIAL - 22209, PRE-OPERATIVE AUTOMATIC IMAGE FUSION - 22210, ULTRASOUND KIT - 22520, ULTRASOUND REGISTRATION PHANTOM DRAPE (20 PCS.) - 22531, ULTRASOUND SOFTWARE EXTERNAL INTEGRATION - 22560, IGSONIC ADVANCED COLOR DOPPLER MODES - 22584, IGSONIC SOFTWARE - 22585, IGSONIC PROBE DRAPE 10V5 (20 PCS.) - 22598, LEICA M500N SOFTWARE - 22610, LEICA M500N SOFTWARE WITH ROBOTICS - 22611, LEICA M520 SOFTWARE - 22612, LEICA M520 SOFTWARE WITH ROBOTICS - 22613, LEICA M525 SOFTWARE - 22614, LEICA M525 SOFTWARE WITH ROBOTICS - 22615, LEICA M720 SOFTWARE - 22616, LEICA M720 SOFTWARE WITH ROBOTICS - 22617, MOELLER HIR1000 SOFTWARE WITH ROBOTICS - 22620, MOELLER VM900/MMS900 SOFTWARE WITH ROBOTICS - 22621, MOELLER VM900/MMS900 SOFTWARE - 22622, MOELLER HIR1000 SOFTWARE - 22623, MOELLER HIR700 SOFTWARE - 22624, OLYMPUS OME SOFTWARE WITH ROBOTICS - 22625, OLYMPUS OME SOFTWARE - 22626, ZEISS OPMI NEURO SOFTWARE - 22631, ZEISS OPMI PENTERO SOFTWARE - 22633, ZEISS OPMI PENTERO SOFTWARE WITH ROBOTICS - 22634, ZEISS OPMI VARIO SOFTWARE - 22635, LIVE VIDEO DISPLAY - 22700, TRANSFER PET/SPECT DICOM NET - 36002, TRANSFER ''ANALYZE'' NET (fMRI) - 36020, VARIO REFERENCE CLAMP KIT - 41736, DISPOSABLE REFLECTIVE MARKER SPHERES - 41774, DISPOSABLE BIOPSY NEEDLE (5 PCS.) 1.8MM / 150MM - 41779, ERASER POINTER TIP SET - 41783, INSTRUMENT ADAPTER ARRAY SIZE ML - 41799, INSTRUMENT CALIBRATION MATRIX (Rev.4) - 41874, INDIVIDUAL INSTRUMENT ADAPTATION FOR FRAMELESS BIOPSY SYSTEM - 41946, SKULL REFERENCE ARRAY - 52120, DRILL BIT 1.1MM - 52126, HANDLE FOR DRILL BIT 1.1MM - 52127, DISPOSABLE REGISTRATION MARKER CT - 52150, DISPOSABLE REGISTRATION MARKER MR - 52151, DISPOSABLE REGISTRATION MARKER OR - 52152, BL POINTER, SHARP TIP (WITH GAUGE) - 53105, BL POINTER, BLUNT TIP (WITH GAUGE) - 53106, POINTER TIP SET (5 PCS.) - 55051, INSTRUMENT ADAPTER KIT (4), STARLINK INTERFACE - 55060, INSTRUMENT ADAPTER KIT (2), STARLINK INTERFACE - 55065, STERILIZATION TRAY FRAMELESS BIOPSY - 55204, STERILIZATION TRAY VARIOGUIDE - 55205, MULTIPLE-TIP-POINTER SHAFT, STARLINK INTERFACE - 55791, BRAINLAB FRAMELESS BIOPSY SYSTEM - 55940, VARIOGUIDE - 55950, IGSONIC SOFTWARE ADDITIONAL LICENSE - 22585-01, TRANSFER CT DICOM NET / CD / MOD - 31000-0, TRANSFER CT DICOM ON NAVIGATION PLATFORM - 31000-3, TRANSFER MR DICOM NET / CD / MOD - 35000-0, TRANSFER MR DICOM ON NAVIGATION PLATFORM - 35000-3, TRANSFER MR DICOM BOLD GE (ADDITIONAL LICENSE) - 35001-1, TRANSFER MR DICOM BOLD SIEMENS (ADDITIONAL LICENSE) - 35002-1, TRANSFER MR DICOM BOLD PHILIPS (ADDITIONAL LICENSE) - 35003-1, TRANSFER MR DICOM DTI GE (ADDITIONAL LICENSE) - 35011-1, TRANSFER MR DICOM DTI SIEMENS (ADDITIONAL LICENSE) - 35012-1, TRANSFER MR DICOM DTI PHILIPS (ADDITIONAL LICENSE) - 35013-1, MICROSCOPE ADAPTER KIT MOELLER-WEDEL - 41767-01, MICROSCOPE ADAPTER KIT LEICA - 41767-04, MICROSCOPE ADAPTER KIT OLYMPUS - 41767-07, MICROSCOPE ADAPTER KIT ZEISS - 41767-16, LINK TO LOCAL NETWORK - 50200-1, STERILIZATION TRAY CRANIAL - 55202-01, BASIC CRANIAL ACCESSORY PACKAGE - B11000, CRANIAL REFERENCE PACKAGE - B11001, SKULL REFERENCE PACKAGE - B11002, FRAMELESS BIOPSY PACKAGE - B11003, VARIOGUIDE PACKAGE - B11004, INSTRUMENT ADAPTER PACKAGE (SET OF 2) - B11005, INSTRUMENT ADAPTER PACKAGE (SET OF 4) - B11006, SOFTOUCH & Z-TOUCH REGISTRATION PACKAGE - B11100, SOFTOUCH CT/MR REGISTRATION PACKAGE - B11101, Z-TOUCH CT/MR REGISTRATION PACKAGE - B11102, SOFTOUCH PACKAGE FOR Z-TOUCH USER - B11103, VV TRAINING PHANTOM CRANIAL - D-10009, KOLIBRI NAVIGATION STATION 2.0 (WITH MOBILE CAMERA STAND 2.0) - 19506, VECTORVISION FLEX - 16500, VECTORVISION COMPACT NAVIGATION STATION - 17000, VECTORVISION2 NAVIGATION STATION - 16000, DISPOSABLE STYLET (10 PCS) - 55797, Z-TOUCH LASER POINTER - 41990, IGSONIC INTEGRATED ULTRASOUND SYSTEM 3000 - 22570, IGSONIC 3000 PROBE 12L5 - 22578, IGSONIC 3000 PROBE 7L3 - 22579, SOFTOUCH REGISTRATION POINTER - 18390, TOUCH SCREEN DRAPE (40 PCS.) - 16122, STANDARD CRANIAL REFERENCE ARRAY - 41735, STANDARD CRANIAL REFERENCE ARRAY (2 PCS) - 41738, CURVE CEILING-MOUNTED SINGLE DISPLAY - 15705, CURVE CEILING-MOUNTED DUAL DISPLAY - 15700, REFERENCE CLAMP UNIVERSAL - 41734, REFERENCE CLAMP UNIVERSAL (WITH 2 ARRAYS) - 41730, STANDARD CRANIAL REFERENCE ARRAY WITH 4 MARKER SPHERES (1PC.) - 41725, STANDARD CRANIAL REFERENCE ARRAY WITH 4 MARKER SPHERES (2PCS.) - 41728, NAVIGATION SOFTWARE CRANIAL - 22214, NAVIGATION SOFTWARE ENT - 22215

승인 날짜:

2011-11-22