FDA 510(k) Applications for Medical Device Product Code "JAI"
(Couch, Radiation Therapy, Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K042146 ACCURAY INCORPORATED ROBOCOUCH PATIENT SUPPORT SYSTEM 09/17/2004
K993522 AKTINA MEDICAL PHYSICS CORP. AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT 01/10/2000
K982446 AMERICAN BIOPHYSICS, INC. DYNAMIC SHIELDING RADIATION TABLE 09/29/1998
K120520 BRAINLAB AG EXACTRAC ROBOTICS NOVALIS ROBOTICS 06/29/2012
K033316 BRAINLAB AG TABLE TILT DEVICE 05/14/2004
K182683 Chinan Biomedical Technology, Inc. Z-Robot Patient Positioning System 06/27/2019
K983678 ELEKTA INSTRUMENTS, INC. ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE 01/15/1999
K122413 FORTE AUTOMATION SYSTEMS, INC. PATIENT POSITIONING SYSTEM 09/13/2012
K170502 Forte Automation Systems, Inc. Patient Positioning System 04/13/2017
K160518 LEONI CIA CABLE SYSTEM LEONI ORION System 07/14/2016
K060870 MDS NORDION AVANZA 05/15/2006
K122201 MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS PROTURA COUCH SOFTWARE 08/30/2012
K132084 MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS PROTURA COUCH SOFTWARE 09/26/2013
K031866 MED-TEC,INC. MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC 08/14/2003
K034054 MED-TEC,INC. PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 02/20/2004
K072898 MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH HEXAPOD EVO RT COUCH TOP 10/25/2007
K071870 MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH HEXAPOD RT COUCH TOP 07/08/2007
K041448 MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH HEXAPOD RT COUCHTOP 06/16/2004
K062639 MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MODIFICATION TO HEXAPOD RT COUCH TOP 09/21/2006
K013036 NOMOS CORP. NOMOS MOTORIZED CRANE II 12/07/2001
K964740 NOMOS CORP. THE NOMOS MINICRANE 02/11/1997
K050422 SIEMENS MEDICAL SOLUTIONS USA, INC. 550 TXT TREATMENT TABLE 03/18/2005
K060671 WFR/AQUAPLAST CORP. KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS 05/04/2006
K120916 WFR/AQUAPLAST CORP. QFIX RADIOTHERAPY CHAIR 06/20/2012


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