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510(k) K120520

Device
EXACTRAC ROBOTICS NOVALIS ROBOTICS
Applicant
BRAINLAB AG
510(k) number
K120520
Product code
JAI  
Decision
Substantially Equivalent (SESE)
Decision date
2012-06-29
Date received
2012-02-21
Regulation
892.5770
Classification name
Couch, Radiation Therapy, Powered
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALEXANDER SCHWIERSCH
Address
Kapellenstrasse 12 Feldkirchen DE 85622 85622

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JAI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231612Eve Patient Positioner SystemLeo Cancer Care2024-05-07
K182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc.2019-06-27
K170502Patient Positioning SystemForte Automation Systems, Inc.2017-04-13
K160518LEONI ORION SystemLeoni Cia Cable System2016-07-14
K132084PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions2013-09-26
K122413PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.2012-09-13
K122201PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions2012-08-30
K120916QFIX RADIOTHERAPY CHAIRWfr/Aquaplast Corp.2012-06-20
K072898HEXAPOD EVO RT COUCH TOPMedical Intelligence Medizintechnik GmbH2007-10-25
K071870HEXAPOD RT COUCH TOPMedical Intelligence Medizintechnik GmbH2007-07-08
K062639MODIFICATION TO HEXAPOD RT COUCH TOPMedical Intelligence Medizintechnik-GmbH-An Elekta2006-09-21
K060870AVANZAMds Nordion2006-05-15
K060671KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSWfr/Aquaplast Corp.2006-05-04
K050422550 TXT TREATMENT TABLESiemens Medical Solutions USA, Inc.2005-03-18
K042146ROBOCOUCH PATIENT SUPPORT SYSTEMAccuray Incorporated2004-09-17

Legacy Summary#

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FDA Review#

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