Interventional Fluoroscopic X-ray System

Device Code: 5418

Product Code(s): OWB

Definition: Interventional Fluoroscopy

Device Classification Information

• Device Type ID: 5418
• Device Name: Interventional Fluoroscopic X-ray System
• Physical State: Fluoroscopic X-Ray System
• Technical Method: Fluoroscopy
• Target Area: Human Body
• Regulation Description: Image-intensified Fluoroscopic 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: 892.1650 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OWB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-286 NEMA XR 27 Amendment 1-2013
  X-ray Equipment For Interventional Procedures - User Quality Control Mode
• 12-290 IEC 61910-1 Edition 1.0 2014-09
  Medical Electrical Equipment - Radiation Dose Documentation - Part 1: Radiation Dose Structured Reports For Radiography And Radioscopy
• 12-296 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
  Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Radiography And Radioscopy
• 12-317 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
  Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Radiography And Radioscopy [Including: Amendment 2 (2018)]

Total Product Life Cycle

• Device Type ID: 5418
• Device: Interventional Fluoroscopic X-ray System
• Product Code: OWB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Image-intensified Fluoroscopic X-ray System.
• CFR Regulation Number: 892.1650 [🔎]

Premarket Reviews
Manufacturer	Decision
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
CANON, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	5
GE OEC MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GEMSS MEDICAL SYSTEMS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GENERAL ELECTRIC CO.
	SUBSTANTIALLY EQUIVALENT	4
GENORAY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
NRT X-RAY A/S
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
OMEGA MEDICAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS DMC GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	6
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
	SUBSTANTIALLY EQUIVALENT	1
SAFERAY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHIMADZU CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	10
SIEMENS CAPITAL
	SUBSTANTIALLY EQUIVALENT	8
SIEMENS MEDICAL SOLUTION USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
THERENVA SAS
	SUBSTANTIALLY EQUIVALENT	1
TOSHIBA
	SUBSTANTIALLY EQUIVALENT	12
TOSHIBA MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	12
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
ZIEHM IMAGING GMBH
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Device Inoperable	3666
Device Stops Intermittently	1699
Device Displays Incorrect Message	1629
Device Operates Differently Than Expected	1139
Electrical /Electronic Property Problem	478
Failure To Power Up	478
Application Interface Becomes Non-Functional Or Program Exits Abnormally	389
Communication Or Transmission Problem	345
Loss Of Data	259
Difficult To Open Or Close	199
Application Program Freezes, Becomes Nonfunctional	195
Fuse	173
Insufficient Information	171
Calibration Problem	130
Circuit Board	129
Computer Software Problem	127
Mechanical Problem	113
Patient Data Problem	105
Loss Of Power	94
Battery	91
Material Deformation	76
Positioning Problem	73
Cover	72
Poor Quality Image	61
Display Or Visual Feedback Problem	56
Device Remains Activated	48
System	44
Noise, Audible	40
Device Sensing Problem	40
Imprecision	39
Arcing	36
Failure To Run On Battery	36
No Display / Image	32
Cable	31
Detachment Of Device Component	29
Output Problem	29
Charger	27
Wireless Communication Problem	27
Unintended Movement	26
Break	25
Detachment Of Device Or Device Component	24
Failure To Charge	21
Adverse Event Without Identified Device Or Use Problem	21
Application Program Problem	20
Use Of Device Problem	19
No Apparent Adverse Event	19
Computer Operating System Problem	18
Controller	16
Failure To Obtain Sample	14
Bent	12
CPU (Central Processing Unit Of Computer System)	11
Monitor	10
Mechanical Jam	10
Keyboard	10
Unexpected Shutdown	10
Image Display Error / Artifact	9
Physical Resistance / Sticking	9
Detector	9
Failure To Fire	8
No Device Output	8
Failure To Shut Off	7
Power Problem	7
Improper Or Incorrect Procedure Or Method	6
Device Damaged Prior To Use	6
Installation-Related Problem	6
Device Emits Odor	5
Erratic Or Intermittent Display	5
Connector	5
Missing Value Reason	5
Power Switch	5
Sparking	5
Device Operational Issue	4
Data Problem	4
Premature Discharge Of Battery	4
Intermittent Communication Failure	4
Computer Hardware	4
Calibration Error	4
Component Falling	4
Loose Or Intermittent Connection	4
Electrical Shorting	4
Power Cord	4
Image Reversal	3
Device Handling Problem	3
Radiation Output Problem	3
Circuit Failure	3
Intermittent Continuity	3
Screw	3
Device Difficult To Setup Or Prepare	3
Radiation Overexposure	3
Defective Component	3
Pin	3
LED (Light Emitting Diode)	3
Material Twisted / Bent	3
Problem With Software Installation	2
Unintended Application Program Shut Down	2
Fire	2
Fracture	2
CRT (Cathode Ray Tube)	2
Failure To Calibrate	2
Appropriate Term/Code Not Available	2
Total Device Problems	12886

Recalls
Manufacturer		Recall Class	Date Posted
1	Barco N.V.	II	Nov-30-2018
2	GE Healthcare	II	Jul-20-2015
3	GE Healthcare	II	Jul-03-2015
4	GE Healthcare	II	Jan-14-2015
5	GE Healthcare, LLC	II	Dec-23-2016
6	GE Healthcare, LLC	II	Dec-16-2014
7	GE Healthcare, LLC	II	Mar-10-2014
8	GE Healthcare, LLC	II	Feb-03-2014
9	GE Medical Systems, LLC	II	May-23-2016
10	GE Medical Systems, LLC	II	Feb-05-2016
11	GE Medical Systems, SCS	II	Oct-05-2018
12	GE OEC Medical Systems, Inc	II	Jan-20-2017
13	GE OEC Medical Systems, Inc	II	Jan-09-2017
14	GE OEC Medical Systems, Inc	II	Aug-23-2016
15	GE OEC Medical Systems, Inc	II	Nov-07-2014
16	GE OEC Medical Systems, Inc	II	Apr-16-2014
17	Medtronic Navigation, Inc.	II	Mar-08-2016
18	Medtronic Navigation, Inc.-Littleton	II	Nov-07-2018
19	Medtronic Navigation, Inc.-Littleton	II	Mar-08-2018
20	Medtronic Navigation, Inc.-Littleton	II	Oct-11-2016
21	Medtronic Navigation, Inc.-Littleton	II	Jul-06-2016
22	Philips Electronics North America Corporation	II	Sep-21-2018
23	Philips Electronics North America Corporation	II	May-01-2018
24	Philips Electronics North America Corporation	II	Feb-24-2018
25	Philips Electronics North America Corporation	II	Feb-24-2018
26	Philips Electronics North America Corporation	II	Dec-18-2017
27	Philips Electronics North America Corporation	II	Apr-14-2017
28	Philips Electronics North America Corporation	II	Jan-20-2017
29	Philips Electronics North America Corporation	II	Aug-26-2016
30	Philips Electronics North America Corporation	II	Mar-07-2016
31	Philips Electronics North America Corporation	II	Feb-05-2016
32	Philips Electronics North America Corporation	II	Jan-30-2016
33	Philips Healthcare	II	Jul-25-2018
34	Philips Medical Systems Nederlands	II	Jun-27-2018
35	Philips Medical Systems, Inc.	II	Dec-01-2015
36	Philips Medical Systems, Inc.	II	Nov-07-2014
37	Philips Medical Systems, Inc.	II	Oct-09-2014
38	Philips North America, LLC	II	Mar-23-2019
39	Regulatory Insight, Inc	II	Feb-24-2016
40	Shimadzu Medical Systems Usa Com	II	Feb-21-2019
41	Shimadzu Medical Systems Usa Com	II	Oct-19-2018
42	Siemens Medical Solutions USA, INC	II	Feb-14-2018
43	Siemens Medical Solutions USA, Inc	II	Mar-07-2019
44	Siemens Medical Solutions USA, Inc	II	Nov-14-2018
45	Siemens Medical Solutions USA, Inc	II	Sep-18-2018
46	Siemens Medical Solutions USA, Inc	II	Aug-11-2018
47	Siemens Medical Solutions USA, Inc	II	Jul-20-2018
48	Siemens Medical Solutions USA, Inc	II	Jul-20-2018
49	Siemens Medical Solutions USA, Inc	II	Jun-27-2018
50	Siemens Medical Solutions USA, Inc	II	Jun-22-2018
51	Siemens Medical Solutions USA, Inc	II	Mar-20-2018
52	Siemens Medical Solutions USA, Inc	II	Feb-23-2018
53	Siemens Medical Solutions USA, Inc	II	Feb-23-2018
54	Siemens Medical Solutions USA, Inc	II	Feb-03-2018
55	Siemens Medical Solutions USA, Inc	II	Aug-29-2017
56	Siemens Medical Solutions USA, Inc	II	Mar-19-2017
57	Siemens Medical Solutions USA, Inc	II	Mar-14-2017
58	Siemens Medical Solutions USA, Inc	II	Jan-09-2017
59	Siemens Medical Solutions USA, Inc	II	Nov-17-2016
60	Siemens Medical Solutions USA, Inc	II	Mar-31-2016
61	Siemens Medical Solutions USA, Inc	II	Mar-31-2016
62	Siemens Medical Solutions USA, Inc	II	Mar-31-2016
63	Siemens Medical Solutions USA, Inc	II	Mar-31-2016
64	Siemens Medical Solutions USA, Inc	II	Dec-24-2015
65	Siemens Medical Solutions USA, Inc	II	Oct-23-2015
66	Siemens Medical Solutions USA, Inc	II	Aug-18-2015
67	Siemens Medical Solutions USA, Inc	II	Aug-05-2015
68	Siemens Medical Solutions USA, Inc	II	Jul-02-2015
69	Siemens Medical Solutions USA, Inc	II	Jun-25-2015
70	Siemens Medical Solutions USA, Inc	II	May-23-2015
71	Siemens Medical Solutions USA, Inc	II	Apr-14-2015
72	Siemens Medical Solutions USA, Inc	II	Feb-17-2015
73	Siemens Medical Solutions USA, Inc	II	Jan-14-2015
74	Siemens Medical Solutions USA, Inc	II	Sep-16-2014
75	Siemens Medical Solutions USA, Inc	II	Jun-04-2014
76	Siemens Medical Solutions USA, Inc	II	Mar-27-2014
77	Stephanix	II	Dec-05-2018
78	Toshiba American Medical Systems Inc	II	Mar-02-2018
79	Toshiba American Medical Systems Inc	II	Aug-30-2017
80	Toshiba American Medical Systems Inc	II	May-30-2017
81	Toshiba American Medical Systems Inc	II	Jul-18-2016
82	Toshiba American Medical Systems Inc	II	Feb-09-2016
83	Toshiba American Medical Systems Inc	II	Apr-06-2015
84	Ziehm Imaging Inc	II	May-17-2017
85	Ziehm Imaging Inc	II	Aug-25-2016

TPLC Last Update: 2019-04-02 21:05:53