Image-intensified Fluoroscopic X-ray System, Mobile

Device Code: 5419

Product Code(s): OXO

Definition: Fluoroscopy Of The Human Body.

Device Classification Information

• Device Type ID: 5419
• Device Name: Image-intensified Fluoroscopic X-ray System, Mobile
• Physical State: Hardware
• Technical Method: X-ray Transmission Through Human Body
• 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: OXO
• 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: 5419
• Device: Image-intensified Fluoroscopic X-ray System, Mobile
• Product Code: OXO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Image-intensified Fluoroscopic X-ray System.
• CFR Regulation Number: 892.1650 [🔎]

Premarket Reviews
Manufacturer	Decision
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
GE OEC MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GEMSS MEDICAL SYSTEMS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GENERAL ELECTRIC CO.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
SKANRAY TECHNOLOGIES PVT LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Operates Differently Than Expected	3446
Electrical /Electronic Property Problem	1829
Device Displays Incorrect Message	1148
Device Inoperable	1077
Communication Or Transmission Problem	837
Battery	752
Computer Software Problem	500
Cable	416
Difficult To Open Or Close	378
Fuse	351
Mechanical Problem	330
Application Program Freezes, Becomes Nonfunctional	306
Circuit Board	306
Poor Quality Image	266
Device Stops Intermittently	254
Application Interface Becomes Non-Functional Or Program Exits Abnormally	234
Display Or Visual Feedback Problem	193
Charger	172
CPU (Central Processing Unit Of Computer System)	164
Calibration Problem	157
Material Deformation	156
Cover	144
No Display / Image	138
Positioning Problem	87
Break	75
Computer Hardware	73
Failure To Run On Battery	69
Failure To Power Up	68
Imprecision	67
Controller	62
No Device Output	58
Monitor	52
Application Program Problem	48
Connector	48
Adverse Event Without Identified Device Or Use Problem	44
Power Cord	43
Device Emits Odor	42
Use Of Device Problem	37
Unexpected Shutdown	34
Power Switch	34
Failure To Charge	30
Thermal Decomposition Of Device	27
Noise, Audible	26
Unintended Movement	24
Detector	21
Sparking	20
Improper Device Output	18
Failure To Calibrate	17
Failure To Obtain Sample	16
Electrical Wire	16
Keyboard	15
Failure To Fire	15
Device Sensing Problem	15
Hinge	13
Insufficient Information	13
Image Display Error / Artifact	12
Bent	12
LED (Light Emitting Diode)	11
Physical Resistance / Sticking	11
Device Damaged By Another Device	11
Display	11
Pin	10
Unstable	10
Power Problem	10
Motherboard	10
Premature Discharge Of Battery	9
Frame	9
Fracture	9
Naturally Worn	9
Wireless Communication Problem	8
Emergency Stop Button Or Switch	7
Erratic Or Intermittent Display	7
Data Problem	7
Battery Problem	6
Unintended Application Program Shut Down	6
Application Program Problem: Dose Calculation Error	6
Image Reversal	6
Spring	6
Device Issue	6
Intermittent Loss Of Power	5
Output Problem	5
Material Frayed	5
Smoking	5
Screw	5
Caster	3
Material Twisted / Bent	3
Foot Switch	3
Fan	3
Handpiece	3
Loose Or Intermittent Connection	3
Loss Of Power	3
Motor	3
Arcing	2
Complete Blockage	2
Issue With Displayed Error Message	2
Defective Component	2
Patient-Device Incompatibility	2
Device Difficult To Setup Or Prepare	2
Component Missing	1
Power Supply	1
Total Device Problems	15053

Recalls
Manufacturer		Recall Class	Date Posted
1	GE OEC Medical Systems, Inc	II	Feb-27-2017
2	GE OEC Medical Systems, Inc	II	Jan-09-2017
3	GE OEC Medical Systems, Inc	II	Oct-11-2016
4	GE OEC Medical Systems, Inc	II	Jun-08-2015
5	GE OEC Medical Systems, Inc	II	Jan-13-2015
6	GE OEC Medical Systems, Inc	II	Nov-07-2014
7	Medtronic Navigation, Inc.	II	Feb-28-2014
8	Medtronic Navigation, Inc.-Littleton	II	Oct-25-2018
9	Medtronic Navigation, Inc.-Littleton	II	Mar-08-2018
10	Medtronic Navigation, Inc.-Littleton	II	Jul-06-2016
11	Orthoscan, Inc.	II	Jan-09-2018

TPLC Last Update: 2019-04-02 21:05:56