System, X-ray, Tomography, Computed

Device Code: 5360

Product Code(s): JAK

Device Classification Information

• Device Type ID: 5360
• Device Name: System, X-ray, Tomography, Computed
• Regulation Description: Computed Tomography X-ray System.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.1750 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JAK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-225 NEMA XR 25
  Computed Tomography Dose Check
• 12-226 IEC 61223-2-6 Second Edition 2006-11
  Evaluation And Routine Testing In Medical Imaging Departments - Part 2-6: Constancy Tests - Imaging Performance Of Computed Tomography X-ray Equipment
• 12-270 IEC 61223-3-5 First Edition 2004-08
  Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)]
• 12-287 NEMA XR 28-2013
  Supplemental Requirements For User Information And System Function Related To Dose In CT
• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice For Three-Dimensional (3D) Medical Modeling
• 12-300 NEMA PS 3.1 - 3.20 (2016)
  Digital Imaging And Communications In Medicine (DICOM) Set
• 12-302 IEC 60601-2-44 Edition 3.2: 2016
  Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Computed Tomography

Total Product Life Cycle

• Device Type ID: 5360
• Device: System, X-ray, Tomography, Computed
• Product Code: JAK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Computed Tomography X-ray System.
• CFR Regulation Number: 892.1750 [🔎]

Premarket Reviews
Manufacturer	Decision
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