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
529–552 of 822
Cleared Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141
Shimadzu Corp.
Radiology · 81d
Cleared Jun 15, 2001
MX8000 V5.0 CT SYSTEM
K010817
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160
E-Z-Em, Inc.
Radiology · 30d
Cleared Mar 30, 2001
GE CT-PET SYSTEM
K010641
Ge Medical Systems, Inc.
Radiology · 25d
Cleared Jan 30, 2001
CT PERFUSION 2
K010042
General Electric Co.
Radiology · 25d
Cleared Jan 23, 2001
VITREA 2 CT PERFUSION OPTION
K003639
Vital Images, Inc.
Radiology · 60d
Cleared Dec 27, 2000
V SCORE WITH AUTO GATE MODEL TBD
K003230
Vital Images, Inc.
Radiology · 72d
Cleared Nov 17, 2000
CT CORD IQ OPTION 1.0
K003408
GE Medical Systems
Radiology · 15d
Cleared Oct 24, 2000
SOMATOM SMILE
K003152
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 12, 2000
SOMATOM EMOTION MS
K003014
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978
GE Medical Systems
Radiology · 15d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682
Vital Images, Inc.
Radiology · 29d
Cleared Jun 22, 2000
ULTRASIM CT SYSTEM
K001088
Philips Medical Systems (Cleveland), Inc.
Radiology · 79d
Cleared May 12, 2000
PHILIPS CT SECURA MV
K000819
Philips Medical Systems North America, Inc.
Radiology · 60d
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431
Shimadzu Medical Systems
Radiology · 84d
Cleared Feb 15, 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Dec 21, 1999
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
K993645
Ge Medical Systems, Inc.
Radiology · 54d
Cleared Nov 24, 1999
CT PERFUSION OPTION
K993791
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 24, 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 09, 1999
EBT ULTRAFAST CT SCANNER SYSTEM
K992740
Imatron, Inc.
Radiology · 85d
Cleared Aug 17, 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Aug 10, 1999
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
K991766
Toshiba America Medical Systems, In.C
Radiology · 78d
Cleared Jun 18, 1999
HISPEED NX/I CT SCANNER SYSTEM
K991716
Ge Medical Systems, Inc.
Radiology · 29d
Cleared Jun 09, 1999
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K991600
Siemens Corp.
Radiology · 30d