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
313–336 of 822
Cleared May 23, 2012
SOMATOM PERSPECTIVE
K113287
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
K113732
Brainlab AG
Radiology · 140d
Cleared May 03, 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K113341
Hitachi Medical Systems America, Inc.
Radiology · 171d
Cleared Apr 10, 2012
AQUILION CXL
K112989
Toshiba America Medical Systems, In.C
Radiology · 187d
Cleared Apr 06, 2012
AQUILION PRIME
K120710
Toshibamedical Systems Corporation
Radiology · 29d
Cleared Jan 26, 2012
AQUILION PRIME
K110066
Toshiba America Medical Systems, In.C
Radiology · 381d
Cleared Nov 22, 2011
SAFIRE
K103424
Siemens Medical Solutions USA, Inc.
Radiology · 365d
Cleared Sep 09, 2011
GE VEO RECONSTRUCTION OPTION
K103489
General Electric Co.
Radiology · 287d
Cleared Aug 25, 2011
AQUILION LB MOVEMENT BASE KIT
K111633
Toshiba America Medical Systems, In.C
Radiology · 73d
Cleared Jul 20, 2011
OPTIMA CT660
K110227
Ge Medical Systems, LLC
Radiology · 176d
Cleared Apr 19, 2011
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
K093581
Ge Medical Systems, LLC
Radiology · 517d
Cleared Apr 08, 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888
Hitachi Medical Systems America, Inc.
Radiology · 275d
Cleared Mar 11, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102102
VATECH Co., Ltd.
Radiology · 227d
Cleared Mar 04, 2011
SOMATOM DEFINITION AS
K103127
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Feb 18, 2011
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259
VATECH Co., Ltd.
Radiology · 192d
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 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747
Philips Medical Systems (Cleveland), Inc.
Radiology · 31d
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