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..

822
Total
822
Cleared
108d
Avg days
1976
Since
822 devices
337–360 of 822
Cleared Dec 17, 2008
PHILIPS MODEL MX 16 SLICE CT SYSTEM
K083498
Philips Medical Systems (Cleveland), Inc.
Radiology · 22d
Cleared Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282
Toshiba America Medical Systems, In.C
Radiology · 35d
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 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 09, 2008
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
K073695
J. Morita USA, Inc.
Radiology · 100d
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 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 Nov 01, 2007
CSNP-001A NEURO PACKAGE
K072693
Toshiba America Medical Systems, In.C
Radiology · 38d
Cleared Oct 05, 2007
CSCS-001A CALCIUM SCORING PACKAGE
K072737
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 02, 2007
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
K072606
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Aug 28, 2007
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Jun 13, 2007
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378
E-Z-Em, Inc.
Radiology · 27d
Cleared Mar 23, 2007
PET VCAR
K063324
Ge Healthcare
Radiology · 140d
Cleared Nov 09, 2006
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
K063241
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 03, 2006
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
K063184
Toshiba America Medical Systems, In.C
Radiology · 14d