XKNIFE RADIOSURGERY SYSTEM

Company Name INTEGRA RADIONICS, INC.
Address 22 TERRY AVENUE
City, State / Province, ZIP / Postal Code BURLINGTON, MA 01803
Country US
FDA Owner/Operator Phone 609-275-0500
FDA Medical Specialty Code RA - Radiology
FDA Product Code KPQ
FDA Classification Name SYSTEM, SIMULATION, RADIATION THERAPY
FDA Device Classification Code Standards
FDA Regulation Number 892.5840
FDA Common Generic Name LINAC-BASED RADIOSURGERY TREATMENT PLANNING SYSTEM
FDA Proprietary Device Name XKNIFE RADIOSURGERY SYSTEM
FDA Owner / Operator Number 9004007
FDA Owner / Operator Name INTEGRA LIFESCIENCES CORPORATION
FDA Establishment Registration Number 1222895
FDA Registered Establishment Name INTEGRA RADIONICS, INC.
FDA Operation Code(s) MM - Manufacturer
RR - Repackager/Relabeller

Competitors of INTEGRA RADIONICS, INC.

Our records indicate that the following medical device companies may manufacture a similar device.

  Company Name Proprietary Device Name Common Generic Device Name
1 AKTINA MEDICAL PHYSICS CORP. SIMULATOR ACCESSORIES SCCESSORIES FOR RADIATION THERAPY SIMULATOR
2 ELEKTA LTD. MULTIPLE LOCALIZER/SIMULATOR SYSTEM
3 GE MEDICAL SYSTEMS SCS MULTIPLE TYPES OF RADIATION THERAPY SIMULATORS
4 HUESTIS MACHINE CORP. HUESTIS MEDICAL-CASCADE SIMULATOR SYSTEM, SIMULATION, RADIATION THERAPY
5 IMPAC MEDICAL SYSTEMS, INC. QWIKSIM VIRTUAL SIMULATION SYSTEM
6 IZI MEDICAL PRODUCTS INC. SHADOWFORM RADIOGRAPHIC MARKERS
7 MEDTEC I.Z. PORT RADIATION THERAPY SKIN MARKERS (CORNERS, ISOCENTERS, STANDARD)
8 NUCLETRON B.V. SIMULIX, THERAPAX, EVOLUTION SIMULATOR
9 PROWESS, INC. PROWESS RADIATION THERAPY TREATMENT PLANNING SYSTEM
10 RADIATION PRODUCTS DESIGN, INC. MULTIPLE VARIOUS ELECTRON CONES, TRAY ADAPTIONS & COUCH PANELS,INSERTS,EXTENSIONS, RACKET
11 TIANJIN LONGXING (GROUP) HUANYU,IMP.&EXP.CO.,LTD. ZHOU LIN BIO-FREQUENCY SPECTRUM DEVICE ZHOU LIN BIO-FREQUENCY SPECTRUM DEVICE
12 VARIAN MEDICAL SYSTEMS UK LTD. XIMATRON SCANVISION XIMATRON SCANVISION


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