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Panels › Radiology › Product code JAK · Class 2

System, X-Ray, Tomography, Computed

Regulation 892.1750

22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Jan 27, 2015Mobius Imaging, LLC
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Terminated
JAKK131431
Jan 26, 2015GE Healthcare
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconn
Terminated
JAKK133705
Jan 15, 2015GE Healthcare
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Terminated
JAKK133705
Jan 15, 2015Philips Medical Systems (Cleveland) Inc
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray tran
Terminated
JAKK012009
K033326 +2
Jan 14, 2015Siemens Medical Solutions USA, Inc
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at
Terminated
JAKK133589
Dec 16, 2014Philips Medical Systems (Cleveland) Inc
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array wi
Terminated
JAKK083498
K091195
Dec 16, 2014Philips Medical Systems, Inc.
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body
Terminated
JAKK060937
Dec 1, 2014Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number;
Terminated
JAKK132524
Nov 26, 2014Toshiba American Medical Systems Inc
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm det
Terminated
JAKK113466
Nov 26, 2014Toshiba American Medical Systems Inc
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector
Terminated
JAKK132222
Sep 29, 2014Philips Medical Systems (Cleveland) Inc
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transm
Terminated
JAKK033326
Sep 26, 2014Philips Medical Systems (Cleveland) Inc
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of
Terminated
JAKK010817
K033326
Sep 18, 2014Philips Medical Systems (Cleveland) Inc
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same a
Terminated
JAKK033357
Sep 18, 2014Philips Medical Systems (Cleveland) Inc
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different
Terminated
JAKK033326
Aug 14, 2014Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server
Terminated
JAKK012009
K033326 +2
Jun 22, 2014Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bor
Terminated
JAKK033357
Jun 4, 2014Philips Medical Systems (Cleveland) Inc
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
Terminated
JAKK010817
K012009 +3
Jun 4, 2014Siemens Medical Solutions USA, Inc
Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission d
Terminated
JAKK023687
K042328 +1
Apr 16, 2014Philips Medical Systems (Cleveland) Inc
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are
Terminated
JAKK012009
K033326 +2
Mar 20, 2014GE Healthcare, LLC
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-
Terminated
JAKK093581
Mar 6, 2014Toshiba American Medical Systems Inc
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Terminated
JAKK132222
Mar 6, 2014GE Healthcare, LLC
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4
Terminated
JAKK081105
Mar 3, 2014Toshiba American Medical Systems Inc
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium
Terminated
JAKK080211
K113466 +1
Feb 3, 2014Siemens Medical Solutions USA, Inc
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Terminated
JAKK103127
K113342 +2
Jan 29, 2014Philips Medical Systems (Cleveland) Inc
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the
Terminated
JAKK033326
K033357 +1
Jan 27, 2014Philips Medical Systems (Cleveland) Inc
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to pro
Terminated
JAKK060937
Jan 27, 2014GE Healthcare, LLC
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different an
Terminated
JAKK082816
K123596
Jan 27, 2014Philips Medical Systems (Cleveland) Inc
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and plane
Terminated
JAKK060937
Jan 21, 2014Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by
Terminated
JAKK033357
Nov 15, 2013Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstru
Terminated
JAKK060937
Oct 17, 2013Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are
Terminated
JAKK012009
K033357
Oct 17, 2013Philips Medical Systems (Cleveland) Inc
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
Terminated
JAKK083498
Oct 17, 2013GE Healthcare, LLC
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK110227
Sep 16, 2013Philips Medical Systems (Cleveland) Inc
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional i
Terminated
JAKK012009
K033326
Aug 9, 2013GE Healthcare, LLC
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data take
Terminated
JAKK081105
Jul 2, 2013Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce c
Terminated
JAKK033326
Jun 25, 2013Philips Medical Systems (Cleveland) Inc
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction
Terminated
JAKK033326
Jun 18, 2013GE Healthcare, LLC
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5
Terminated
JAKK063324
May 20, 2013Philips Medical Systems (Cleveland) Inc
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 ID
Terminated
JAKK012009
Apr 29, 2013GE Healthcare, LLC
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray tr
Terminated
JAKK013561
K030420 +3
Apr 23, 2013Philips And Neusoft Medical Systems Co., Ltd.
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section im
Terminated
JAKK071308
Apr 23, 2013Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body c
Terminated
JAKK090173
K092742
Apr 17, 2013Philips Healthcare Inc.
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row det
Terminated
JAKNone listed
Apr 12, 2013Philips Medical Systems (Cleveland) Inc
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewin
Terminated
JAKNone listed
Apr 8, 2013Toshiba American Medical Systems Inc
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Terminated
JAKK122109
Apr 8, 2013Toshiba American Medical Systems Inc
TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
Terminated
JAKNone listed
Mar 14, 2013Philips Medical Systems (Cleveland) Inc
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the bod
Terminated
JAKK033326
Mar 14, 2013Siemens Medical Solutions USA, Inc
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Terminated
JAKK122471
Mar 13, 2013Philips Medical Systems (Cleveland) Inc
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are int
Terminated
JAKK010817
K012009 +3
Mar 5, 2013Philips Medical Systems (Cleveland) Inc
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is i
Terminated
JAKK961464

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