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)
Top companies in JAK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2015 | Mobius Imaging, LLC Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. Terminated |
JAK | K131431 |
| Jan 26, 2015 | GE 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 |
JAK | K133705 |
| Jan 15, 2015 | GE Healthcare GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner. Terminated |
JAK | K133705 |
| Jan 15, 2015 | Philips 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 |
JAK | K012009 K033326 +2 |
| Jan 14, 2015 | Siemens 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 |
JAK | K133589 |
| Dec 16, 2014 | Philips 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 |
JAK | K083498 K091195 |
| Dec 16, 2014 | Philips 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 |
JAK | K060937 |
| Dec 1, 2014 | Philips 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 |
JAK | K132524 |
| Nov 26, 2014 | Toshiba 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 |
JAK | K113466 |
| Nov 26, 2014 | Toshiba 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 |
JAK | K132222 |
| Sep 29, 2014 | Philips 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 |
JAK | K033326 |
| Sep 26, 2014 | Philips 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 |
JAK | K010817 K033326 |
| Sep 18, 2014 | Philips 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 |
JAK | K033357 |
| Sep 18, 2014 | Philips 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 |
JAK | K033326 |
| Aug 14, 2014 | Philips 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 |
JAK | K012009 K033326 +2 |
| Jun 22, 2014 | Philips 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 |
JAK | K033357 |
| Jun 4, 2014 | Philips 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 |
JAK | K010817 K012009 +3 |
| Jun 4, 2014 | Siemens 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 |
JAK | K023687 K042328 +1 |
| Apr 16, 2014 | Philips 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 |
JAK | K012009 K033326 +2 |
| Mar 20, 2014 | GE 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 |
JAK | K093581 |
| Mar 6, 2014 | Toshiba American Medical Systems Inc TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Terminated |
JAK | K132222 |
| Mar 6, 2014 | GE 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 |
JAK | K081105 |
| Mar 3, 2014 | Toshiba 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 |
JAK | K080211 K113466 +1 |
| Feb 3, 2014 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems.
X-ray tomography, computed, radiology. Terminated |
JAK | K103127 K113342 +2 |
| Jan 29, 2014 | Philips 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 |
JAK | K033326 K033357 +1 |
| Jan 27, 2014 | Philips 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 |
JAK | K060937 |
| Jan 27, 2014 | GE 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 |
JAK | K082816 K123596 |
| Jan 27, 2014 | Philips 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 |
JAK | K060937 |
| Jan 21, 2014 | Philips 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 |
JAK | K033357 |
| Nov 15, 2013 | Philips 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 |
JAK | K060937 |
| Oct 17, 2013 | Philips 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 |
JAK | K012009 K033357 |
| Oct 17, 2013 | Philips Medical Systems (Cleveland) Inc MX 16-Slice CT Scanner System.
Used as a whole-body computed tomography X-Ray system. Terminated |
JAK | K083498 |
| Oct 17, 2013 | GE Healthcare, LLC GE, Optima CT660.
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | K110227 |
| Sep 16, 2013 | Philips 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 |
JAK | K012009 K033326 |
| Aug 9, 2013 | GE 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 |
JAK | K081105 |
| Jul 2, 2013 | Philips 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 |
JAK | K033326 |
| Jun 25, 2013 | Philips 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 |
JAK | K033326 |
| Jun 18, 2013 | GE 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 |
JAK | K063324 |
| May 20, 2013 | Philips 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 |
JAK | K012009 |
| Apr 29, 2013 | GE 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 |
JAK | K013561 K030420 +3 |
| Apr 23, 2013 | Philips 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 |
JAK | K071308 |
| Apr 23, 2013 | Philips 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 |
JAK | K090173 K092742 |
| Apr 17, 2013 | Philips 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 |
JAK | None listed |
| Apr 12, 2013 | Philips 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 |
JAK | None listed |
| Apr 8, 2013 | Toshiba American Medical Systems Inc Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Terminated |
JAK | K122109 |
| Apr 8, 2013 | Toshiba 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 |
JAK | None listed |
| Mar 14, 2013 | Philips 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 |
JAK | K033326 |
| Mar 14, 2013 | Siemens Medical Solutions USA, Inc Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B.
Computed tomography x-ray system. Terminated |
JAK | K122471 |
| Mar 13, 2013 | Philips 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 |
JAK | K010817 K012009 +3 |
| Mar 5, 2013 | Philips 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 |
JAK | K961464 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.