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)
Aug 30, 2005	Philips Medical Systems (Cleveland) Inc Brillance 16, 10, and 6 configuration (watercooled version) using 1.0, 1.1, 1.2, 1.2.2, or 1.2.4 software. Terminated	JAK	K012009
Aug 30, 2005	Philips Medical Systems (Cleveland) Inc Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software. Terminated	JAK	K010817
Aug 30, 2005	Philips Medical Systems (Cleveland) Inc Brilliance CT System, 40 channel configuration using version 1.2 software. Terminated	JAK	K033326
Jul 6, 2005	Philips Medical Systems (Cleveland) Inc AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips. Terminated	JAK	K001088
Jul 6, 2005	Philips Medical Systems (Cleveland) Inc Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips. Terminated	JAK	K955268
Feb 16, 2005	E-Z-EM, Inc Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: T Terminated	JAK	K011160 K031571
Feb 16, 2005	E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and Terminated	JAK	K011160 K031571
Feb 16, 2005	E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and Terminated	JAK	K011160 K031571
Nov 3, 2004	Siemens Medical Solutions USA, Inc LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534 Terminated	JAK	K010938
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015 Terminated	JAK	K013522
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106 Terminated	JAK	None listed
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation Cardiac, Computed Tomography X-Ray, Model Number 75 43 106 Terminated	JAK	K013522
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73 93 114. Terminated	JAK	K013522
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model Number 73 93 114 Terminated	JAK	K013522
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Emotion 6, Computed Tomography X-Ray System, Model Number: 38 15 490 Terminated	JAK	K023687
Nov 3, 2004	Siemens Medical Solutions USA, Inc SOMATOM CT System Emotion Duo, X-Ray, Tomography, Computed System, Model number 38 13 933 Terminated	JAK	K003014
Jul 20, 2004	Toshiba American Med Sys Inc Computed Tomography, Models TSX-101A and TSX-021A. Terminated	JAK	K982265 K982787
Jul 20, 2004	Philips Medical Systems (Cleveland) Inc Philips Brilliance CT Scanner System, 6, 10 & 16 slice images. Terminated	JAK	K012009
Jul 20, 2004	Philips Medical Systems (Cleveland) Inc Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. Terminated	JAK	K012009
May 15, 2003	Philips Medical Systems (Cleveland) Inc Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. Terminated	JAK	K010817
May 15, 2003	Philips Medical Systems (Cleveland) Inc Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Terminated	JAK	K012009
Mar 21, 2003	Toshiba American Med Sys Inc X-ray, Computed Tomography, Model TSX101A Terminated	JAK	None listed

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