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
409–432 of 827
Cleared Nov 18, 2010
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
K093891
Toshibamedical Systems Corporation
Radiology · 335d
Cleared Oct 07, 2010
I-LOGIC INREACH SYSTEM
K102604
Superdimension, Ltd.
Radiology · 27d
Cleared Aug 04, 2010
ICAD VERALOOK CTC CAD SOFTWARE
K091529
Icad, Inc.
Radiology · 439d
Cleared Jun 18, 2010
BF-NAVI
K093810
Kgt, Inc.
Radiology · 189d
Cleared May 26, 2010
SYNGO.CT CORONARY ANALYSIS
K100637
Siemens AG Medical Solutions
Radiology · 82d
Cleared Mar 11, 2010
IGUIDE CAPPA
K093787
Cas Innovations GmbH & Co. KG
Radiology · 92d
Cleared Jan 27, 2010
IG 4 IMAGE GUIDED SYSTEM
K093995
Veran Medical Technologies, Inc.
Radiology · 30d
Cleared Dec 02, 2009
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
K091934
Veran Medical Technologies, Inc.
Radiology · 155d
Cleared Nov 30, 2009
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
K093146
Veran Medical Technologies, Inc.
Radiology · 56d
Cleared Oct 09, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
K090991
E-Woo Technology
Radiology · 185d
Cleared Oct 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747
Philips Medical Systems (Cleveland), Inc.
Radiology · 31d
Cleared Sep 22, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K092742
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Sep 04, 2009
INREACH SYSTEM, MODEL AAS00161-02
K092365
Superdimension, Ltd.
Radiology · 30d
Cleared Jul 17, 2009
SYNGO VOLUME PERFUSION-CT BODY
K092013
Siemens AG Medical Solutions
Radiology · 11d
Cleared Jun 24, 2009
GE LIGHTSPEED ACT FP16
K091673
Ge Medical Systems, Inc.
Radiology · 15d
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