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
577–600 of 827
Cleared Sep 25, 2001
ACCUIMAGE SMARTGATE UPGRADE
K012106
Accuimage Diagnostics Corp.
Radiology · 81d
Cleared Sep 13, 2001
MX8000 IDT CT SYSTEM
K012009
Marconi Medical Systems, Inc.
Radiology · 78d
Cleared Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836
GE Medical Systems
Radiology · 15d
Cleared Aug 10, 2001
HISPEED X/I SMART GANTRY OPTION
K012385
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 07, 2001
CT COLONOGRAPHY/NAVIGATOR2
K012313
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Aug 03, 2001
IN SPACE 3D
K011447
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141
Shimadzu Corp.
Radiology · 81d
Cleared Jun 27, 2001
CT/MASTER, VERSION 1.0
K011180
Columbia Scientific, Inc.
Radiology · 71d
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 May 07, 2001
SIMPLICT
K010813
Neorad AS
Radiology · 49d
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 Jan 18, 2001
MRI LINE MARKER
K003736
I.Z.I. Corp.
Radiology · 45d
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 Sep 22, 2000
BOLUSPRO ULTRA
K002005
Marconi Medical Systems, Inc.
Radiology · 81d
Cleared Aug 08, 2000
ULTRAGUIDE CT-GUIDE 1010
K002258
Ultraguide , Ltd.
Radiology · 14d
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