System, X-ray, Tomography, Computed

Device Code: 5360

Product Code(s): JAK

Device Classification Information

Device Type ID5360
Device NameSystem, X-ray, Tomography, Computed
Regulation DescriptionComputed Tomography X-ray System.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.1750 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJAK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5360
DeviceSystem, X-ray, Tomography, Computed
Product CodeJAK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionComputed Tomography X-ray System.
CFR Regulation Number892.1750 [🔎]
Premarket Reviews
ManufacturerDecision
ANALOGIC CORP.
 
SUBSTANTIALLY EQUIVALENT
2
ANALOGIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
2
ARINETA LTD.
 
SUBSTANTIALLY EQUIVALENT
1
CANON MEDICAL SYSTEMS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
CEFLA S.C.
 
SUBSTANTIALLY EQUIVALENT
1
CLEAR GUIDE MEDICAL
 
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN LLC
 
SUBSTANTIALLY EQUIVALENT
2
CURVEBEAM
 
SUBSTANTIALLY EQUIVALENT
2
EDDA TECHNOLOGY
 
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
7
GENERAL ELECTRIC CO.
 
SUBSTANTIALLY EQUIVALENT
7
HITACHI HEALTHCARE AMERICAS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
HITACHI MEDICAL CORP.
 
SUBSTANTIALLY EQUIVALENT
4
HITACHI MEDICAL SYSTEMS AMERICA, INC.
 
SUBSTANTIALLY EQUIVALENT
4
IMBIO
 
SUBSTANTIALLY EQUIVALENT
1
ISYS MEDIZINTECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
1
KONICA MINOLTA, INC.
 
SUBSTANTIALLY EQUIVALENT
2
MOBIUS IMAGING, LLC
 
SUBSTANTIALLY EQUIVALENT
1
NEOCOIL, LLC
 
SUBSTANTIALLY EQUIVALENT
1
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS)
 
SUBSTANTIALLY EQUIVALENT
1
NEUSOFT MEDICAL SYSTEMS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
4
NEUWAVE MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
1
NEUWAVE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
2
PARITIC INC
 
SUBSTANTIALLY EQUIVALENT
1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
8
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
 
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
6
QI IMAGING, LLC
 
SUBSTANTIALLY EQUIVALENT
1
QR S.R.L.
 
SUBSTANTIALLY EQUIVALENT
1
SIEMENS
 
SUBSTANTIALLY EQUIVALENT
38
SIEMENS CAPITAL
 
SUBSTANTIALLY EQUIVALENT
34
SIEMENS HEALTHCARE GMBH
 
SUBSTANTIALLY EQUIVALENT
1
SIEMENS MEDICAL SOLUTIONS USA, INC.
 
SUBSTANTIALLY EQUIVALENT
1
SIEMENS MEDICAL SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
2
TOSHIBA
 
SUBSTANTIALLY EQUIVALENT
16
TOSHIBA MEDICAL SYSTEMS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
16
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
 
SUBSTANTIALLY EQUIVALENT
1
VARIAN MEDICAL SYSTEMS, INC
 
SUBSTANTIALLY EQUIVALENT
1
VERAN MEDICAL TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
1
VITAL IMAGES, INC.
 
SUBSTANTIALLY EQUIVALENT
3
Device Problems
Adverse Event Without Identified Device Or Use Problem
328
Device Operates Differently Than Expected
132
Mechanical Problem
104
Unintended System Motion
44
Detachment Of Device Or Device Component
31
Detachment Of Device Component
26
Signal Artifact
26
Unintended Movement
22
Use Of Device Problem
20
Device Displays Incorrect Message
18
Device Operational Issue
18
Improper Or Incorrect Procedure Or Method
16
Insufficient Information
16
Material Fragmentation
14
Application Network Problem
13
Positioning Problem
13
Computer Software Problem
11
Output Problem
11
Human-Device Interface Problem
11
Programming Issue
11
Incorrect, Inadequate Or Imprecise Result Or Readings
10
Mechanical Jam
9
Image Display Error / Artifact
8
Leak / Splash
8
Poor Quality Image
7
Patient Data Problem
7
Calibration Problem
7
Device Stops Intermittently
7
Electrical /Electronic Property Problem
7
Connection Problem
6
Break
6
Material Deformation
6
Incorrect Or Inadequate Test Results
5
Inadequate User Interface
5
Data Problem
5
Improper Device Output
4
Output Above Specifications
4
Device Slipped
4
Disconnection
4
Loose Or Intermittent Connection
4
Sticking
4
Device Handling Problem
4
Computer Operating System Problem
3
Installation-Related Problem
3
Unintended Collision
3
Thermal Decomposition Of Device
3
Table Top
3
Overheating Of Device
3
Smoking
3
Battery Problem
3
Radiation Overexposure
3
Fire
3
Table
2
Material Integrity Problem
2
Power Problem
2
Device Inoperable
2
No Display / Image
2
Incorrect Measurement
2
Activation, Positioning Or Separation Problem
2
No Apparent Adverse Event
2
Display Or Visual Feedback Problem
2
Temperature Problem
2
Noise, Audible
2
Malposition Of Device
2
Difficult To Advance
2
Mechanics Altered
2
Component Falling
2
Device Issue
2
Human Factors Issue
2
Patient Device Interaction Problem
2
Loss Of Power
2
Failure To Power Up
1
Inadequate Or Insufficient Training
1
Application Program Problem
1
Component Or Accessory Incompatibility
1
Device Emits Odor
1
Ring
1
Electromagnetic Interference
1
Program Or Algorithm Execution Problem
1
Environmental Compatibility Problem
1
Motor
1
Monitor
1
Device Maintenance Issue
1
Chemical Spillage
1
Device Misassembled During Manufacturing / Shipping
1
Wiring Harness
1
Device Alarm System
1
Volume Accuracy Problem
1
Difficult To Insert
1
Defective Device
1
EKG/ECG Monitor
1
Gears
1
Panel
1
Difficult To Position
1
Premature Activation
1
Device Dislodged Or Dislocated
1
Physical Property Issue
1
Device Abrasion From Instrument Or Another Object
1
Seal
1
Component Missing
1
Total Device Problems 1113
Recalls
Manufacturer Recall Class Date Posted
1
Bayer Medical Care, Inc.
II Aug-31-2018
2
Brainlab AG
II Feb-03-2018
3
GE Healthcare
II Sep-21-2015
4
GE Healthcare
II May-15-2015
5
GE Healthcare
II Jan-26-2015
6
GE Healthcare
II Jan-15-2015
7
GE Healthcare Japan Corporation
II Aug-17-2018
8
GE Healthcare, LLC
II Feb-06-2019
9
GE Healthcare, LLC
II Jul-31-2018
10
GE Healthcare, LLC
II Jun-12-2017
11
GE Healthcare, LLC
II Jun-06-2016
12
GE Healthcare, LLC
II Mar-20-2014
13
GE Healthcare, LLC
II Mar-06-2014
14
GE Healthcare, LLC
II Jan-27-2014
15
GE Medical Systems, LLC
II Apr-29-2016
16
GE Medical Systems, LLC
II Mar-04-2016
17
GE Medical Systems, LLC
II Dec-10-2015
18
Hitachi Medical Systems America Inc
II Aug-17-2018
19
Hitachi Medical Systems America Inc
II Aug-11-2016
20
Mobius Imaging, LLC
II Sep-14-2018
21
Mobius Imaging, LLC
II Feb-24-2018
22
Mobius Imaging, LLC
II Jan-27-2015
23
NEUSOFT MEDICAL SYSTEMS IMP & EX
II Feb-05-2019
24
Neusoft Medical System Co
II Jun-16-2015
25
Neusoft Medical Systems Co., Ltd.
II Aug-28-2017
26
Neusoft Medical Systems Co., Ltd.
II Dec-23-2016
27
Neusoft Medical Systems Co., Ltd.
II May-11-2016
28
Northridge Tri-Modality Imaging,
II Sep-30-2016
29
Philips Electronics North America Corporation
II Oct-13-2017
30
Philips Electronics North America Corporation
II Nov-22-2016
31
Philips Electronics North America Corporation
II Dec-12-2015
32
Philips Healthcare
II Jun-06-2016
33
Philips Medical Systems
II Oct-04-2016
34
Philips Medical Systems (Cleveland) Inc
II Nov-30-2018
35
Philips Medical Systems (Cleveland) Inc
II Oct-31-2018
36
Philips Medical Systems (Cleveland) Inc
II Jul-02-2018
37
Philips Medical Systems (Cleveland) Inc
II Jun-22-2018
38
Philips Medical Systems (Cleveland) Inc
II Jun-12-2018
39
Philips Medical Systems (Cleveland) Inc
II Apr-17-2018
40
Philips Medical Systems (Cleveland) Inc
II Apr-17-2018
41
Philips Medical Systems (Cleveland) Inc
II Mar-02-2018
42
Philips Medical Systems (Cleveland) Inc
II Mar-02-2018
43
Philips Medical Systems (Cleveland) Inc
II Feb-09-2018
44
Philips Medical Systems (Cleveland) Inc
II Feb-04-2018
45
Philips Medical Systems (Cleveland) Inc
II Jan-23-2018
46
Philips Medical Systems (Cleveland) Inc
II Jan-19-2018
47
Philips Medical Systems (Cleveland) Inc
II Jan-11-2018
48
Philips Medical Systems (Cleveland) Inc
II Mar-20-2017
49
Philips Medical Systems (Cleveland) Inc
II Jan-20-2017
50
Philips Medical Systems (Cleveland) Inc
II Jan-11-2017
51
Philips Medical Systems (Cleveland) Inc
II Jan-11-2017
52
Philips Medical Systems (Cleveland) Inc
II Dec-02-2016
53
Philips Medical Systems (Cleveland) Inc
III Nov-16-2016
54
Philips Medical Systems (Cleveland) Inc
II Aug-25-2016
55
Philips Medical Systems (Cleveland) Inc
II Aug-10-2016
56
Philips Medical Systems (Cleveland) Inc
II Aug-09-2016
57
Philips Medical Systems (Cleveland) Inc
II Aug-05-2016
58
Philips Medical Systems (Cleveland) Inc
II Jul-01-2016
59
Philips Medical Systems (Cleveland) Inc
II Jun-30-2016
60
Philips Medical Systems (Cleveland) Inc
II Jun-30-2016
61
Philips Medical Systems (Cleveland) Inc
II May-31-2016
62
Philips Medical Systems (Cleveland) Inc
II Apr-15-2016
63
Philips Medical Systems (Cleveland) Inc
II Apr-08-2016
64
Philips Medical Systems (Cleveland) Inc
II Dec-24-2015
65
Philips Medical Systems (Cleveland) Inc
II Dec-10-2015
66
Philips Medical Systems (Cleveland) Inc
II Dec-10-2015
67
Philips Medical Systems (Cleveland) Inc
II Nov-02-2015
68
Philips Medical Systems (Cleveland) Inc
II Oct-30-2015
69
Philips Medical Systems (Cleveland) Inc
II Jul-24-2015
70
Philips Medical Systems (Cleveland) Inc
II Jul-22-2015
71
Philips Medical Systems (Cleveland) Inc
II Jun-11-2015
72
Philips Medical Systems (Cleveland) Inc
II May-29-2015
73
Philips Medical Systems (Cleveland) Inc
II May-22-2015
74
Philips Medical Systems (Cleveland) Inc
II Apr-01-2015
75
Philips Medical Systems (Cleveland) Inc
II Jan-15-2015
76
Philips Medical Systems (Cleveland) Inc
II Dec-16-2014
77
Philips Medical Systems (Cleveland) Inc
II Dec-01-2014
78
Philips Medical Systems (Cleveland) Inc
II Sep-29-2014
79
Philips Medical Systems (Cleveland) Inc
II Sep-26-2014
80
Philips Medical Systems (Cleveland) Inc
II Sep-18-2014
81
Philips Medical Systems (Cleveland) Inc
II Sep-18-2014
82
Philips Medical Systems (Cleveland) Inc
II Aug-14-2014
83
Philips Medical Systems (Cleveland) Inc
II Jun-22-2014
84
Philips Medical Systems (Cleveland) Inc
II Jun-04-2014
85
Philips Medical Systems (Cleveland) Inc
II Apr-16-2014
86
Philips Medical Systems (Cleveland) Inc
II Jan-29-2014
87
Philips Medical Systems (Cleveland) Inc
II Jan-27-2014
88
Philips Medical Systems (Cleveland) Inc
II Jan-27-2014
89
Philips Medical Systems (Cleveland) Inc
II Jan-21-2014
90
Philips Medical Systems, Inc.
II Dec-16-2014
91
Philips And Neusoft Medical Systems Co., Ltd.
II Apr-27-2016
92
Siemens Medical Solutions USA, Inc
II May-25-2018
93
Siemens Medical Solutions USA, Inc
II May-15-2018
94
Siemens Medical Solutions USA, Inc
II Apr-30-2018
95
Siemens Medical Solutions USA, Inc
II Mar-30-2018
96
Siemens Medical Solutions USA, Inc
II Feb-24-2018
97
Siemens Medical Solutions USA, Inc
II Jun-21-2017
98
Siemens Medical Solutions USA, Inc
II Dec-12-2016
99
Siemens Medical Solutions USA, Inc
II Dec-02-2016
100
Siemens Medical Solutions USA, Inc
II Nov-17-2016
101
Siemens Medical Solutions USA, Inc
II Nov-17-2016
102
Siemens Medical Solutions USA, Inc
II Nov-08-2016
103
Siemens Medical Solutions USA, Inc
II Aug-23-2016
104
Siemens Medical Solutions USA, Inc
II Apr-22-2016
105
Siemens Medical Solutions USA, Inc
II Apr-19-2016
106
Siemens Medical Solutions USA, Inc
II Apr-08-2016
107
Siemens Medical Solutions USA, Inc
II Mar-31-2016
108
Siemens Medical Solutions USA, Inc
II Oct-06-2015
109
Siemens Medical Solutions USA, Inc
II Oct-05-2015
110
Siemens Medical Solutions USA, Inc
II Jun-27-2015
111
Siemens Medical Solutions USA, Inc
II May-22-2015
112
Siemens Medical Solutions USA, Inc
II Mar-12-2015
113
Siemens Medical Solutions USA, Inc
II Jan-14-2015
114
Siemens Medical Solutions USA, Inc
II Jun-04-2014
115
Siemens Medical Solutions USA, Inc
II Feb-03-2014
116
Siemens Medical Solutions USA, Inc.
II Jun-08-2018
117
Siemens Medical Solutions USA, Inc.
II May-02-2018
118
Siemens Medical Solutions USA, Inc.
II Jan-21-2016
119
Toshiba American Medical Systems Inc
II Nov-18-2016
120
Toshiba American Medical Systems Inc
II Oct-06-2016
121
Toshiba American Medical Systems Inc
II Apr-22-2016
122
Toshiba American Medical Systems Inc
II Oct-09-2015
123
Toshiba American Medical Systems Inc
II Nov-26-2014
124
Toshiba American Medical Systems Inc
II Mar-06-2014
125
Toshiba American Medical Systems Inc
II Mar-03-2014
126
Xoran Technologies, Inc.
II Jun-26-2015
127
Xoran Technologies, Inc.
II Jun-26-2015
128
Xoran Technologies, Inc.
II Jun-26-2015
129
Xoran Technologies, Inc.
II Jun-26-2015
130
Xoran Technologies, Inc.
II Jun-26-2015
131
Xoran Technologies, LLC
II Mar-02-2015
TPLC Last Update: 2019-04-02 21:04:55

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