System, X-ray, Fluoroscopic, Image-intensified

Device Code: 5352

Product Code(s): JAA

Device Classification Information

• Device Type ID: 5352
• Device Name: System, X-ray, Fluoroscopic, Image-intensified
• 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: JAA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-202 IEC 60601-2-43 - Ed. 2.0 2010-03
  Medical Electrical Equipment - Part 2-43: Particular Requirements For The Safety And Essential Performance Of X-ray Equipment For Interventional Procedures
• 12-230 NEMA XR 24-2008 (R2014)
  Primary User Controls For Interventional Angiography X-ray Equipment
• 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
• 12-308 IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION
  Medical Electrical Equipment - Part 2-43: Particular Requirements For The Safety And Essential Performance Of X-ray Equipment For Interventional Procedures
• 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: 5352
• Device: System, X-ray, Fluoroscopic, Image-intensified
• Product Code: JAA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Image-intensified Fluoroscopic X-ray System.
• CFR Regulation Number: 892.1650 [🔎]

Premarket Reviews
Manufacturer	Decision
AGFA HEALTHCARE N.V.
	SUBSTANTIALLY EQUIVALENT	1
APELEM-DMS GROUP
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH
	SUBSTANTIALLY EQUIVALENT	2
DORNIER MEDTECH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
GENERAL MEDICAL MERATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
MAVIG GMBH
	SUBSTANTIALLY EQUIVALENT	2
OMEGA MEDICAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS DMC GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHIMADZU CORP.
	SUBSTANTIALLY EQUIVALENT	2
SHIMADZU CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STEPHANIX RADIOLOGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
TOSHIBA
	SUBSTANTIALLY EQUIVALENT	2
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOSHIBA MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Failure To Power Up	392
Device Stops Intermittently	315
Device Inoperable	295
Device Displays Incorrect Message	106
Patient Data Problem	89
Loss Of Data	58
Device Operates Differently Than Expected	14
Power Problem	12
Computer Software Problem	12
Detachment Of Device Or Device Component	12
Loose Or Intermittent Connection	10
Connection Problem	9
Device Operational Issue	8
Computer Operating System Problem	8
Unintended Movement	7
Electrical /Electronic Property Problem	7
Operating System Becomes Nonfunctional	6
Failure To Sense	5
Disconnection	5
Component Falling	5
Detachment Of Device Component	4
Use Of Device Problem	4
Unintended System Motion	3
Adverse Event Without Identified Device Or Use Problem	3
Battery Problem	3
Data Problem	3
Mechanical Jam	3
Blocked Connection	3
Insufficient Information	2
Mechanical Problem	1
No Device Output	1
Overheating Of Device	1
Connector	1
Application Program Problem: Power Calculation Error	1
Device Damaged Prior To Use	1
Improper Chemical Reaction	1
Use Of Incorrect Control Settings	1
Plunge	1
Human Factors Issue	1
Installation-Related Problem	1
Material Protrusion / Extrusion	1
Poor Quality Image	1
Unintended Collision	1
Arcing	1
Decoupling	1
Charging Problem	1
Radiation Overexposure	1
Unstable	1
Improper Or Incorrect Procedure Or Method	1
Human-Device Interface Problem	1
Inadequate Service	1
Insufficient Cooling	1
Maintenance Does Not Comply To Manufacturers Recommendations	1
Cautery	1
Total Device Problems	1428

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare	II	Jul-20-2015
2	GE Healthcare	II	Jul-02-2015
3	GE Healthcare, LLC	II	Dec-23-2016
4	GE Healthcare, LLC	II	Oct-02-2014
5	GE Healthcare, LLC	II	Jan-21-2014
6	Hans Pausch Rontgengeratebau Gmbh	II	May-30-2017
7	Philips Electronics North America Corporation	II	Jan-10-2018
8	Philips Medical Systems Gmbh, DMC	II	Feb-12-2019
9	Philips Medical Systems Nederlands	II	Jun-27-2018
10	Philips North America, LLC	II	Mar-23-2019
11	Shimadzu Medical Systems	II	Dec-23-2016
12	Shimadzu Medical Systems	II	Nov-09-2015
13	Siemens Medical Solutions USA, Inc	II	Mar-07-2019
14	Siemens Medical Solutions USA, Inc	II	Jul-20-2018
15	Siemens Medical Solutions USA, Inc	II	Mar-20-2018
16	Siemens Medical Solutions USA, Inc	II	Mar-31-2016
17	Siemens Medical Solutions USA, Inc	II	May-23-2015
18	Siemens Medical Solutions USA, Inc	II	Sep-10-2014
19	Toshiba American Medical Systems Inc	II	Mar-02-2018
20	Toshiba American Medical Systems Inc	II	Oct-17-2017
21	Toshiba American Medical Systems Inc	II	Mar-14-2017
22	Toshiba American Medical Systems Inc	II	Mar-21-2016
23	Ziehm Imaging Inc	II	Aug-25-2016

TPLC Last Update: 2019-04-02 21:04:48