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
721–744 of 827
Cleared Aug 01, 1990
FASTRECON 88 PERIFERAL
K902848
Scientific Technology , Ltd.
Radiology · 34d
Cleared Jul 25, 1990
MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
K900170
Elscint, Inc.
Radiology · 194d
Cleared Jul 09, 1990
FALCON DISK DRIVE SUBSYSTEM
K902643
Sokar, Inc.
Radiology · 24d
Cleared Mar 13, 1990
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
K900660
Philips Medical Systems North America, Inc.
Radiology · 32d
Cleared Mar 08, 1990
TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
K896456
Toshiba America Medical Systems, In.C
Radiology · 115d
Cleared Feb 26, 1990
TCT-300S - UPGRADE
K900233
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Jan 23, 1990
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
K894888
Shimadzu Medical Systems
Radiology · 175d
Cleared Dec 14, 1989
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
K894887
Shimadzu Medical Systems
Radiology · 135d
Cleared Sep 07, 1989
ELSCINT'S EXEL 2400E CT SCANNER
K894542
Elscint, Inc.
Radiology · 49d
Cleared Sep 01, 1989
CT HILIGHT ADVANTAGE
K894269
GE Medical Systems
Radiology · 71d
Cleared Aug 07, 1989
CT SYTEC 3000
K893820
General Electric Co.
Radiology · 76d
Cleared May 18, 1989
QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
K891931
Image Analysis, Inc.
Radiology · 51d
Cleared Feb 27, 1989
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
K884555
Toshiba Medical Systems
Radiology · 119d
Cleared Feb 27, 1989
TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
K884788
Toshiba Medical Systems
Radiology · 104d
Cleared Feb 09, 1989
3D/DENTAL
K885322
Columbia Scientific, Inc.
Radiology · 43d
Cleared Jan 18, 1989
EXEL 1800 AND 1800E CT SCANNER
K884670
Elscint, Inc.
Radiology · 71d
Cleared Jan 18, 1989
EXEL 2400 AND 2400 ELITE CT SCANNERS
K884671
Elscint, Inc.
Radiology · 71d
Cleared Dec 30, 1988
EXEL 905 SERIES CT SCANNER
K884667
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 1002 CT SCANNER
K884668
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 2002 & 2002FS CT SCANNER
K884669
Elscint, Inc.
Radiology · 52d
Cleared Dec 20, 1988
VOXELSCOPE(TM)
K884268
Dynamic Digital Displays, Inc.
Radiology · 70d
Cleared Oct 19, 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305
Toshiba Medical Systems
Radiology · 205d
Cleared Oct 11, 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378
Philips Medical Systems (Cleveland), Inc.
Radiology · 125d
Cleared Sep 02, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
K881674
Shimadzu Precision Instruments, Inc.
Radiology · 137d