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
553–576 of 827
Cleared Nov 22, 2002
SOMATOM EMOTION 6 CT SYSTEMS
K023687
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332
GE Medical Systems
Radiology · 16d
Cleared Oct 11, 2002
E-SPEED EBT SCANNER SYSTEM
K022794
Ge Imatron
Radiology · 49d
Cleared Sep 19, 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919
GE Medical Systems
Radiology · 15d
Cleared Aug 23, 2002
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
K022239
Praxim
Radiology · 43d
Cleared Aug 13, 2002
ULTRAGUIDE CTG 2000SA
K022354
Ultraguide , Ltd.
Radiology · 25d
Cleared Aug 06, 2002
LODOX, MODEL BASELINE
K013999
Lodox Systems (Pty), Ltd.
Radiology · 245d
Cleared Jul 16, 2002
LUNGCARE CT SOFTWARE PACKAGE
K022013
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Jul 09, 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
K022050
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared May 22, 2002
HISPEED DUAL
K021491
Ge Medical Systems, Inc.
Radiology · 13d
Cleared Apr 03, 2002
CT-C3000 SPIRAL CT SCANNER SYSTEM
K020913
Neusoft Digital Medical Systems Co., Ltd.
Radiology · 13d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929
GE Medical Systems
Radiology · 12d
Cleared Mar 26, 2002
CARD IQ ANALYSIS II
K020796
GE Medical Systems
Radiology · 14d
Cleared Mar 22, 2002
PRONTO
K014240
Hitachi Medical Systems America, Inc.
Radiology · 86d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Dec 07, 2001
VIATRONIC V3D CALCIUM SCORING
K013146
Viatronix, Inc.
Radiology · 78d
Cleared Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
K013561
GE Medical Systems
Radiology · 13d
Cleared Nov 07, 2001
GEMINI IMAGING SYSTEM
K013521
Adac Laboratories
Radiology · 15d
Cleared Nov 07, 2001
SOMATOM P30 CT SYSTEMS
K013522
Siemens Medical Systems, Inc.
Radiology · 15d
Cleared Oct 30, 2001
CARDIQ FUNCTION
K013422
GE Medical Systems
Radiology · 15d
Cleared Oct 26, 2001
ADVANCED LUNG ANALYSIS-1
K013381
General Electric Co.
Radiology · 14d
Cleared Oct 05, 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Oct 01, 2001
DOSERIGHT
K012238
Philips Medical Systems North America Co.
Radiology · 76d