JAD · Class II · 21 CFR 892.5900

FDA Product Code JAD: System, Therapeutic, X-ray

Leading manufacturers include Xoft, Inc., Carl Zeiss Surgical GmbH and Icad, Inc..

53
Total
53
Cleared
119d
Avg days
1978
Since
53 devices
25–48 of 53
Cleared Feb 29, 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K072683
Xoft, Inc.
Radiology · 161d
Cleared Jan 09, 2007
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
K063456
Topex, Inc.
Radiology · 55d
Cleared Dec 22, 2005
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K050843
Xoft, Inc.
Radiology · 265d
Cleared May 23, 2005
INTRABEAM SYSTEM
K051055
Carl Zeiss Surgical GmbH
Radiology · 27d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577
Photoelectron Corporation
Radiology · 52d
Cleared Jul 27, 1998
PHOTON RADIOSURGERY SYSTEM PRS400
K980526
Pec Photoelectron Corp.
Radiology · 167d
Cleared Dec 02, 1997
THERAPAX DXT 300 MODEL HF-300
K973315
Pantak, Inc.
Radiology · 90d
Cleared Jul 21, 1997
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952
Victoreen, Inc.
Radiology · 223d
Cleared Jun 20, 1997
PHOTON RADIOSURGERY SYSTEM (PRS)
K964947
Photoelectron Corporation
Radiology · 192d
Cleared Jun 13, 1997
THERAPAX SXT 150
K971074
Pantak, Inc.
Radiology · 81d
Cleared Sep 27, 1996
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
K962613
Gulmay Medical , Ltd.
Radiology · 86d
Cleared Dec 13, 1993
INSTA-FLO
K935209
Medtec, Inc.
Radiology · 45d
Cleared Jan 15, 1993
THERAPAX DXT 300 SERIES 3
K923584
Oldelft Corp. of America
Radiology · 179d
Cleared Nov 29, 1990
HUESTIS FLEXI-BOARD
K904005
Huestis Machine Corp.
Radiology · 92d
Cleared Sep 21, 1990
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Sep 07, 1989
FABFOAM #302
K894683
Jewell Industries
Radiology · 44d
Cleared Dec 21, 1988
CMS RECORD AND VERIFY SYSTEM
K882484
Computerized Medical Systems, Inc.
Radiology · 189d
Cleared Feb 22, 1988
S9 DISPLAY SYSTEM
K874214
O.M.I. Oncology Microsystems, Inc.
Radiology · 129d
Cleared Oct 30, 1987
PLAN-32 SOFTWARE
K871810
Oncology Systems, Inc.
Radiology · 175d
Cleared May 21, 1986
THERAPAX HT 150T
K861431
Old Delft Corp. of America
Radiology · 35d
Cleared Feb 21, 1986
MEVAMATIC 3
K854609
Siemens Medical Laboratories, Inc.
Radiology · 95d
Cleared Feb 21, 1985
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
K844424
Varian Assoc., Inc.
Radiology · 98d
Cleared Dec 08, 1983
RTP-5100-5200-5300 & 5400
K833560
Adac Laboratories
Radiology · 51d
Cleared Jan 22, 1982
RTP-5000
K813439
Adac Laboratories
Radiology · 45d