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

Company	510(k)s	Recalls
Philips Medical Systems (Cleveland), Inc.	24	282
Siemens AG Medical Solutions	117	162
GE Healthcare	7	96
GE Medical Systems	68	29
Philips North America	0	64
Toshiba American Medical Systems Inc	0	40
Toshiba America Medical Systems, In.C	35	0
General Electric Co.	31	0
Shanghai United Imaging Healthcare Co., Ltd.	12	16
Toshibamedical Systems Corporation	27	0

Date	Firm and product	Code	Linked 510(k)
Jul 24, 2015	Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated	JAK	K060937
Jul 24, 2015	Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at diff Terminated	JAK	K060937
Jul 24, 2015	Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken Terminated	JAK	K033326
Jul 22, 2015	Philips Medical Systems (Cleveland) Inc Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems Terminated	JAK	K033326
Jul 22, 2015	Philips Medical Systems (Cleveland) Inc Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at di Terminated	JAK	K033326
Jul 22, 2015	Philips Medical Systems (Cleveland) Inc Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at differ Terminated	JAK	K033326
Jun 30, 2015	Hitachi Medical Systems America Inc Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 Terminated	JAK	K101888
Jun 27, 2015	Siemens Medical Solutions USA, Inc SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at Terminated	JAK	K133424
Jun 27, 2015	Siemens Medical Solutions USA, Inc SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken a Terminated	JAK	K133424
Jun 16, 2015	Neusoft Medical System Co Neusoft NeuViz 64 Multi-slice CT Scanner System Terminated	JAK	K121792
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K012009
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033326
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033326
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033326
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033326
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K060937
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K060937
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K060937
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K012009
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K012009
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033357
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033357
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033326
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K033326
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K091195
Jun 11, 2015	Philips Medical Systems (Cleveland) Inc MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated	JAK	K091195
May 29, 2015	Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-ray system Terminated	JAK	K060937
May 22, 2015	Philips Medical Systems (Cleveland) Inc Ingenuity CT. 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 angles and planes. Terminated	JAK	K033326
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance iCT. 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 angles and planes. Terminated	JAK	K060937
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 6 Air. 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 angles and plane Terminated	JAK	K012009
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 10 Air. 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 angles and plan Terminated	JAK	K012009
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Air. 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 angles and plan Terminated	JAK	K012009
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Water. 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 angles and pl Terminated	JAK	K012009
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Power. 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 angles and pl Terminated	JAK	K012009
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 40. 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 angles and planes. Terminated	JAK	K033326
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT 64. 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 angles and planes. Terminated	JAK	K033326
May 22, 2015	Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Oncology. 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 angl Terminated	JAK	K033357
May 22, 2015	Siemens Medical Solutions USA, Inc SOMATOM Perspective; 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 tak Terminated	JAK	K133590
May 22, 2015	Siemens Medical Solutions USA, Inc SOMATOM Emotion 16, 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 take Terminated	JAK	K133424
May 22, 2015	Philips Medical Systems (Cleveland) Inc MX8000 Dualv. EXP, 728130. 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 angles and Terminated	JAK	K010817
May 22, 2015	Siemens Medical Solutions USA, Inc SOMATOM Emotion 6; 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 Terminated	JAK	K133424
May 15, 2015	GE Healthcare CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector. Terminated	JAK	K013561
May 2, 2015	Neusoft Medical Systems Co., Ltd. NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) Terminated	JAK	K121792
Apr 14, 2015	Philips Electronics North America Corporation Philips Healthcare Ingenuity CT Computed Tomography X-ray system Terminated	JAK	K033326
Apr 14, 2015	Philips Electronics North America Corporation Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system Terminated	JAK	K033326
Apr 14, 2015	Philips Electronics North America Corporation Philips Healthcare Ingenuity Core Computed Tomography X-ray system Terminated	JAK	K033326
Apr 14, 2015	Philips Electronics North America Corporation Philips Healthcare Brilliance 64 Computed Tomography X-ray system Terminated	JAK	K033326
Apr 1, 2015	Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Clevela Terminated	JAK	K033326 K060937
Mar 12, 2015	Siemens Medical Solutions USA, Inc SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectio Terminated	JAK	K133589
Mar 2, 2015	Xoran Technologies, LLC Xoran MiniCAT X-ray imaging device Terminated	JAK	K113421

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