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
409–432 of 822
Cleared Jun 23, 2009
BRILLIANCE DUAL ENERGY OPTION
K090462
Philips Medical Systems (Cleveland), Inc.
Radiology · 120d
Cleared Jun 15, 2009
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
K091103
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195
Philips Medical Systems (Cleveland), Inc.
Radiology · 34d
Cleared Apr 01, 2009
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
K083524
Siemens Medical Solutions USA, Inc.
Radiology · 124d
Cleared Mar 05, 2009
CSBP-001A BODY PERFUSION SYSTEM
K090504
Toshibamedical Systems Corporation
Radiology · 7d
Cleared Feb 11, 2009
COLON VIEW, MODEL CSCV-001A
K090220
Toshibamedical Systems Corporation
Radiology · 13d
Cleared Feb 05, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K090173
Neusoft Medical Systems Co., Ltd.
Radiology · 13d
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 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