JAK · Class II · 21 CFR 892.1750

FDA Product Code JAK: System, X-ray, Tomography, Computed

FDA product code JAK covers computed tomography (CT) systems.

These diagnostic imaging systems use rotating X-ray beams and computer processing to generate detailed cross-sectional and three-dimensional images of the body. CT is widely used in emergency medicine, oncology, cardiology, and surgical planning.

JAK devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Medical Systems, In.C and General Electric Co..

827
Total
827
Cleared
108d
Avg days
1976
Since
827 devices
433–456 of 827
Cleared Dec 05, 2008
VIATRONIX V3D-CARDIAC, REVISION 1.0
K083293
Viatronix, Inc.
Radiology · 25d
Cleared Nov 18, 2008
VIDA PULMONARY WORKSTATION 2 (PW2)
K083227
Vida Diagnostics, Inc.
Radiology · 15d
Cleared Oct 17, 2008
P3T ABDOMEN
K082458
Medrad, Inc.
Radiology · 52d
Cleared Oct 17, 2008
GE XTREME INJECTOR OPTION
K082960
Ge Medical Systems, LLC
Radiology · 14d
Cleared Oct 16, 2008
VB IMAGE VIEWER
K080581
Olympus Medical Systems Corporation
Radiology · 227d
Cleared Oct 10, 2008
SOMATOM FLASH DS
K082220
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Oct 08, 2008
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
K082761
Ge Medical Systems, LLC
Radiology · 16d
Cleared Oct 08, 2008
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
K082816
Ge Medical Systems, LLC
Radiology · 13d
Cleared Sep 02, 2008
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
K082104
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Aug 21, 2008
PICASSO MASTER, ECT AND MASTER 3D
K081847
E-Woo Technology
Radiology · 52d
Cleared Jun 11, 2008
MODIFICATION TO INREACH SYSTEM
K081379
Superdimension, Ltd.
Radiology · 26d
Cleared Jun 11, 2008
CSBP-001A BODY ORGAN PERFUSION SYSTEM
K081482
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 02, 2008
SOMATOM DEFINITION, MODEL AS/AS+
K081022
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105
Ge Healthcare
Radiology · 21d
Cleared Apr 11, 2008
NAVSTATIONIRAD EMT, VERSION 1.1
K080624
Cas Innovations AG
Radiology · 37d
Cleared Apr 09, 2008
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
K073695
J. Morita USA, Inc.
Radiology · 100d
Cleared Mar 31, 2008
INREACH SYSTEM
K080271
Superdimension, Ltd.
Radiology · 59d
Cleared Mar 21, 2008
ZIEHM VISION 2
K073346
Ziehm Imaging, Inc.
Radiology · 113d
Cleared Mar 14, 2008
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
K080211
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 13, 2008
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
K080540
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Feb 26, 2008
CARDIQ EXPRESS VERSION 2.0
K073138
GE Medical Systems
Radiology · 111d
Cleared Feb 26, 2008
CARDIQ FUNCTION XPRESS
K073153
GE Medical Systems SCS
Radiology · 110d
Cleared Feb 07, 2008
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
K073003
Siemens Medi Cal Solutions, Inc.
Radiology · 106d
Cleared Jan 03, 2008
SYNGO VOLUME PERFUSION-CT NEURO
K073238
Siemens AG Medical Solutions
Radiology · 48d