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
Cleared
Dec 21, 2012
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
Veran Medical Technologies, Inc.
Radiology
157d
Cleared
Dec 20, 2012
SYNGO, CT CARDIAC FUNCTION
Siemens Medical Solutions USA, Inc.
Radiology
29d
Cleared
Dec 14, 2012
PERCUNAV
Philips Health Care
Radiology
207d
Cleared
Nov 16, 2012
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
Neusoft Medical Systems Co., Ltd.
Radiology
141d
Cleared
Oct 26, 2012
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
Superdimension, Inc.
Radiology
225d
Cleared
Sep 26, 2012
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
Philips Healthcare (Cleveland)
Radiology
308d
Cleared
Sep 21, 2012
AQUILION ONE VISION, V4.90
Toshiba America Medical Systems, In.C
Radiology
66d
Cleared
Sep 13, 2012
GSI VIEWER WITH VUE OPTION
GE Medical Systems SCS
Radiology
84d
Cleared
Sep 11, 2012
SOMATOM DEFINITION
Siemens Medical Systems, Inc.
Radiology
28d
Cleared
Aug 17, 2012
LUNG VOLUME ANALYSIS
Toshibamedical Systems Corporation
Radiology
242d
Cleared
Jul 26, 2012
AQUILION RXL
Toshibamedical Systems Corporation
Radiology
62d
Cleared
Jul 11, 2012
MINICAT
Xoran Technologies, Inc.
Radiology
236d
Cleared
Jun 18, 2012
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
GE Medical Systems SCS
Radiology
84d
Cleared
Jun 13, 2012
AQUILION PREMIUM
Toshiba Medical Systems Corporation, Japan
Radiology
111d
Cleared
Jun 12, 2012
DISCOVERY CT750 HD
Ge Medical Systems, LLC
Radiology
85d
Cleared
May 23, 2012
SOMATOM PERSPECTIVE
Siemens Medical Solutions USA, Inc.
Radiology
198d
Cleared
May 23, 2012
SOMATOM DEFINITION EDGE
Siemens Medical Systems, Inc.
Radiology
86d
Cleared
May 08, 2012
SOMATOM DEFINITION FLASH
Siemens Medical Systems, Inc.
Radiology
29d
Cleared
May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
Brainlab AG
Radiology
140d
Cleared
May 03, 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
Hitachi Medical Systems America, Inc.
Radiology
171d
Cleared
Apr 13, 2012
CT-GUIDE NEEDLE GUIDANCE SYSTEM
Activiews, Ltd.
Radiology
73d
Cleared
Apr 13, 2012
SYNGO CT DYNAMIC ANGIO
Siemens AG Medical Solutions
Radiology
71d
Cleared
Apr 10, 2012
AQUILION CXL
Toshiba America Medical Systems, In.C
Radiology
187d
Cleared
Apr 10, 2012
AQUILION ONE
Toshiba Medical Systems Coporation, Japan
Radiology
140d