System, X-ray, Stationary

Device Code: 5369

Product Code(s): KPR

Device Classification Information

• Device Type ID: 5369
• Device Name: System, X-ray, Stationary
• Regulation Description: Stationary 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: 892.1680 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KPR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

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: 5369
• Device: System, X-ray, Stationary
• Product Code: KPR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Stationary X-ray System.
• CFR Regulation Number: 892.1680 [🔎]

Premarket Reviews
Manufacturer	Decision
ACROMA AB
	SUBSTANTIALLY EQUIVALENT	1
CARESTREAM HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
CMT MEDICAL TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
CUATTRO, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEL MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
EOS IMAGING
	SUBSTANTIALLY EQUIVALENT	2
GE HUALUN MEDICAL SYSTEMS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
GEMSS MEDICAL SYSTEMS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HALIFAX BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
JPI HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICATECH USA
	SUBSTANTIALLY EQUIVALENT	1
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OSKO, INC.
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ROESYS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	13
SAMSUNG ELECTRONICS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	3
SG HEALTHCARE CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
SHIMADZU CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SIEMENS
	SUBSTANTIALLY EQUIVALENT	6
SIEMENS CAPITAL
	SUBSTANTIALLY EQUIVALENT	3
SOURCE-RAY, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Improper Or Incorrect Procedure Or Method	10
Device Operational Issue	7
Use Of Device Problem	6
Unintended Movement	5
Component Falling	5
Unintended System Motion	4
Adverse Event Without Identified Device Or Use Problem	3
Appropriate Term/Code Not Available	3
Failure To Adhere Or Bond	2
Mechanical Problem	2
Detachment Of Device Component	2
Off-Label Use	2
Installation-Related Problem	2
Device Handling Problem	2
Device Issue	1
Unintended Collision	1
Incorrect Device Or Component Shipped	1
Packaging Problem	1
Insufficient Information	1
Break	1
Wiring Harness	1
Defective Component	1
Data Problem	1
Fire	1
Device Operates Differently Than Expected	1
Structural Problem	1
Device Dislodged Or Dislocated	1
Electrical /Electronic Property Problem	1
Total Device Problems	69

Recalls
Manufacturer		Recall Class	Date Posted
1	AGFA Healthcare Corp.	II	Aug-10-2014
2	AGFA Healthcare Corp.	II	Apr-05-2017
3	Agfa Healthcare NV	II	Sep-25-2018
4	Agfa-Gevaert, N.V.	II	Jan-07-2019
5	Carestream Health Inc	II	Aug-22-2015
6	Carestream Health Inc.	II	Aug-01-2014
7	Carestream Health Inc.	II	Jan-29-2014
8	Carestream Health, Inc.	II	Aug-10-2014
9	Carestream Health, Inc.	II	Jan-27-2014
10	Fujifilm Medical Systems U.S.A., Inc.	II	Dec-10-2017
11	GE Healthcare	II	Mar-06-2015
12	GE Healthcare	II	Jan-12-2015
13	GE Healthcare, LLC	II	Jul-16-2018
14	GE Healthcare, LLC	II	Jul-02-2014
15	NeuroLogica Corporation	II	Mar-02-2018
16	NeuroLogica Corporation	II	Aug-25-2017
17	Philips Electronics North America Corporation	II	Jan-03-2018
18	Philips Electronics North America Corporation	II	Jun-09-2017
19	Philips Electronics North America Corporation	II	Sep-01-2016
20	Philips Electronics North America Corporation	II	Feb-05-2016
21	Philips Healthcare	II	Jun-03-2016
22	Philips Medical Systems (Cleveland) Inc	II	Jan-11-2017
23	Philips Medical Systems Nederlands	II	May-03-2018
24	Philips Medical Systems, Inc.	II	Mar-31-2016
25	Philips Medical Systems, Inc.	II	Dec-03-2015
26	Philips Medical Systems, Inc.	II	May-19-2015
27	Philips Medical Systems, Inc.	II	Mar-06-2015
28	Philips North America, LLC	II	Mar-23-2019
29	Shimadzu Medical Systems Usa Com	II	Jun-29-2017
30	Siemens Medical Solutions USA, Inc	II	Oct-30-2018
31	Siemens Medical Solutions USA, Inc	II	Oct-30-2018
32	Siemens Medical Solutions USA, Inc	II	Oct-04-2016
33	Siemens Medical Solutions USA, Inc	II	May-23-2015
34	Siemens Medical Solutions USA, Inc	II	May-05-2015
35	Siemens Medical Solutions USA, Inc	II	Jan-16-2015
36	Siemens Medical Solutions USA, Inc	II	Oct-02-2014
37	Siemens Medical Solutions USA, Inc	II	Sep-23-2014
38	Siemens Medical Solutions USA, Inc	II	Jun-21-2014
39	Siemens Medical Solutions USA, Inc	II	Jun-04-2014
40	Siemens Medical Solutions USA, Inc	II	Apr-24-2014
41	Swissray	II	Sep-25-2018
42	Swissray	II	Sep-18-2018
43	Visaris DOO	II	May-15-2018

TPLC Last Update: 2019-04-02 21:05:03