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JAI — Couch, Radiation Therapy, Powered Class II

FDA Device Classification

Classification Details

Product Code
JAI
Device Class
Class II
Regulation Number
892.5770
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231612leo cancer careEve Patient Positioner SystemMay 7, 2024
K182683chinan biomedical technologyZ-Robot Patient Positioning SystemJune 27, 2019
K170502forte automation systemsPatient Positioning SystemApril 13, 2017
K160518leoni cia cable systemLEONI ORION SystemJuly 14, 2016
K132084med-tec, inc. d/b/a civco medical solutionsPROTURA COUCH SOFTWARESeptember 26, 2013
K122413forte automation systemsPATIENT POSITIONING SYSTEMSeptember 13, 2012
K122201med-tec, inc. d/b/a civco medical solutionsPROTURA COUCH SOFTWAREAugust 30, 2012
K120520brainlabEXACTRAC ROBOTICS NOVALIS ROBOTICSJune 29, 2012
K120916wfr/aquaplastQFIX RADIOTHERAPY CHAIRJune 20, 2012
K072898medical intelligence medizintechnikHEXAPOD EVO RT COUCH TOPOctober 25, 2007
K071870medical intelligence medizintechnikHEXAPOD RT COUCH TOPJuly 8, 2007
K062639medical intelligence medizintechnik-gmbh-an elektaMODIFICATION TO HEXAPOD RT COUCH TOPSeptember 21, 2006
K060870mds nordionAVANZAMay 15, 2006
K060671wfr/aquaplastKVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSMay 4, 2006
K050422siemens medical solutions usa550 TXT TREATMENT TABLEMarch 18, 2005
K042146accuray incorporatedROBOCOUCH PATIENT SUPPORT SYSTEMSeptember 17, 2004
K041448medical intelligence medizintechnikHEXAPOD RT COUCHTOPJune 16, 2004
K033316brainlabTABLE TILT DEVICEMay 14, 2004
K034054med-tecPRO SERIES COUCH SOFTWARE, MODEL MT-PRO100February 20, 2004
K031866med-tecMED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DACAugust 14, 2003