JAI · Class II · 21 CFR 892.5770

FDA Product Code JAI: Couch, Radiation Therapy, Powered

Leading manufacturers include Nomos Corp., Medical Intelligence Medizintechnik GmbH and Siemens Medical Solutions USA, Inc..

32
Total
32
Cleared
105d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Couch, Radiation Therapy, Powered Devices (Product Code JAI)

32 devices
1–24 of 32
Cleared May 07, 2024
Eve Patient Positioner System
K231612
Leo Cancer Care
Radiology · 340d
Cleared Jun 27, 2019
Z-Robot Patient Positioning System
K182683
Chinan Biomedical Technology, Inc.
Radiology · 274d
Cleared Apr 13, 2017
Patient Positioning System
K170502
Forte Automation Systems, Inc.
Radiology · 51d
Cleared Jul 14, 2016
LEONI ORION System
K160518
Leoni Cia Cable System
Radiology · 141d
Cleared Sep 26, 2013
PROTURA COUCH SOFTWARE
K132084
Med-Tec, Inc. D/B/A Civco Medical Solutions
Radiology · 83d
Cleared Sep 13, 2012
PATIENT POSITIONING SYSTEM
K122413
Forte Automation Systems, Inc.
Radiology · 36d
Cleared Aug 30, 2012
PROTURA COUCH SOFTWARE
K122201
Med-Tec, Inc. D/B/A Civco Medical Solutions
Radiology · 36d
Cleared Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
K120520
Brainlab AG
Radiology · 129d
Cleared Jun 20, 2012
QFIX RADIOTHERAPY CHAIR
K120916
Wfr/Aquaplast Corp.
Radiology · 85d
Cleared Oct 25, 2007
HEXAPOD EVO RT COUCH TOP
K072898
Medical Intelligence Medizintechnik GmbH
Radiology · 14d
Cleared Jul 08, 2007
HEXAPOD RT COUCH TOP
K071870
Medical Intelligence Medizintechnik GmbH
Radiology · 2d
Cleared Sep 21, 2006
MODIFICATION TO HEXAPOD RT COUCH TOP
K062639
Medical Intelligence Medizintechnik-GmbH-An Elekta
Radiology · 15d
Cleared May 15, 2006
AVANZA
K060870
Mds Nordion
Radiology · 46d
Cleared May 04, 2006
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
K060671
Wfr/Aquaplast Corp.
Radiology · 51d
Cleared Mar 18, 2005
550 TXT TREATMENT TABLE
K050422
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Sep 17, 2004
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146
Accuray Incorporated
Radiology · 39d
Cleared Jun 16, 2004
HEXAPOD RT COUCHTOP
K041448
Medical Intelligence Medizintechnik GmbH
Radiology · 15d
Cleared May 14, 2004
TABLE TILT DEVICE
K033316
Brainlab AG
Radiology · 212d
Cleared Feb 20, 2004
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
K034054
Med-Tec,Inc.
Radiology · 52d
Cleared Aug 14, 2003
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
K031866
Med-Tec,Inc.
Radiology · 59d
Cleared Dec 07, 2001
NOMOS MOTORIZED CRANE II
K013036
Nomos Corp.
Radiology · 88d
Cleared Jan 10, 2000
AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
K993522
Aktina Medical Physics Corp.
Radiology · 84d
Cleared Jan 15, 1999
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
K983678
Elekta Instruments, Inc.
Radiology · 87d
Cleared Sep 29, 1998
DYNAMIC SHIELDING RADIATION TABLE
K982446
American Biophysics, Inc.
Radiology · 76d

About Product Code JAI - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code JAI since 1983, with 32 receiving FDA clearance (average review time: 105 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.