Accelerator, Linear, Medical

Device Code: 5321

Product Code(s): IYE

Device Classification Information

Device Type ID	5321
Device Name	Accelerator, Linear, Medical
Regulation Description	Medical Charged-particle Radiation Therapy 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	892.5050 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	IYE
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

12-217 IEC 62083 Edition 2.0 2009-09
Medical Electrical Equipment - Requirements For The Safety Of Radiotherapy Treatment Planning Systems
12-241 IEC 62274 First Edition 2005-05
Medical Electrical Equipment - Safety Of Radiotherapy Record And Verify Systems
12-253 IEC 60976 Edition 2.0 2007-10
Medical Electrical Equipment - Medical Electron Accelators - Functional Performance Characteristics
12-255 IEC 60601-2-11 Edition 3.0 2013-01
Medical Electrical Equipment - Part 2-11: Particular Requirements For The Basic Safety And Essential Performance Of Gamma Beam Therapy Equipment
12-267 IEC 61217 Edition 2.0 2011-12
Radiotherapy Equipment - Coordinates, Movements, And Scales
12-285 IEC 60601-2-1 Edition 3.1 2014-07
Medical Electrical Equipment - Part 2-1: Particular Requirements For The Basic Safety And Essential Performance Of Electron Accelerators In The Range 1 MeV To 50 MeV
12-304 IEC 60731 Edition 3.1 2016-04
Consolidated Version Medical Electrical Equipment - Dosimeters With Ionization Chambers As Used In Radiotherapy
12-307 AAMI RT2:2017
Radiation Therapy Readiness Check
12-319 IEC 60601-2-68 Edition 1.0 2014-09
Medical Electrical Equipment - Part 2-68: Particular Requirements For The Basic Safety And Essential Performance Of X-ray-based Image-guided Radiotherapy Equipment For Use With Electron Accelerators, Light Ion Beam Therapy Equipment And Radionuclide Beam Therapy Equipment

Total Product Life Cycle

Device Type ID	5321
Device	Accelerator, Linear, Medical
Product Code	IYE
FDA Device Classification	Class 2 Medical Device
Regulation Description	Medical Charged-particle Radiation Therapy System.
CFR Regulation Number	892.5050 [🔎]

Premarket Reviews
Manufacturer	Decision
ACCURAY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	6
AURORA TECHNOLOGY DEVELOPMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEST MEDICAL INTERNA
	SUBSTANTIALLY EQUIVALENT	1
BIONIX DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIONX
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CARBON MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CNMC CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
CORTEX MANUFACTURING, INC.
	SUBSTANTIALLY EQUIVALENT	1
DOSISOFT
	SUBSTANTIALLY EQUIVALENT	1
ELEKTA AB
	SUBSTANTIALLY EQUIVALENT	4
Elekta Instrument AB
	SUBSTANTIALLY EQUIVALENT	3
ELEKTA LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOCAL THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
IBA DOSIMETRY AMERICA
	SUBSTANTIALLY EQUIVALENT	1
IMPAC
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
LAP OF AMERICA LASER APPLICATIONS LLC
	SUBSTANTIALLY EQUIVALENT	1
MACROMEDICS BV
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDPHOTON GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
MEDTEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MITSUBISHI HEAVY INDUSTRIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOBIUS MEDICAL SYSTEMS, LP
	SUBSTANTIALLY EQUIVALENT	3
NASLUND MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1
ORFIT INDUSTRIES
	SUBSTANTIALLY EQUIVALENT	1
ORFIT INDUSTRIES NV
	SUBSTANTIALLY EQUIVALENT	5
QUALIFORMED SARL
	SUBSTANTIALLY EQUIVALENT	1
RADFORMATION, INC.
	SUBSTANTIALLY EQUIVALENT	2
RADIALOGICA LLC
	SUBSTANTIALLY EQUIVALENT	1
RADIATION PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
RADIATION PRODUCTS DESIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
SCANDIDOS AB
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS
	SUBSTANTIALLY EQUIVALENT	3
SIEMENS CAPITAL
	SUBSTANTIALLY EQUIVALENT	3
SIT-SORDINA IORT TECHNOLOGIES SPA
	SUBSTANTIALLY EQUIVALENT	1
SUN NUCLEAR CORPORATION
	SUBSTANTIALLY EQUIVALENT	8
VARIAN
	SUBSTANTIALLY EQUIVALENT	18
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	17
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
VIEWRAY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
VIEWRAY, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
VISCUS BIOLOGICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
VISION RT LTD
	SUBSTANTIALLY EQUIVALENT	1
WFR/AQUAPLAST CORPORATION/ANHOLT TECHNOLOGIES INC., DBA QFIX
	SUBSTANTIALLY EQUIVALENT	4
ZDI, SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Computer Software Problem	204
Device Operates Differently Than Expected	25
Adverse Event Without Identified Device Or Use Problem	15
Use Of Device Problem	10
Improper Or Incorrect Procedure Or Method	9
Component Falling	9
Unintended Collision	6
No Apparent Adverse Event	6
Compatibility Problem	5
Material Integrity Problem	4
Use Of Incorrect Control Settings	4
Computer Operating System Problem	4
Positioning Problem	4
Loose Or Intermittent Connection	4
Fluid Leak	4
Mechanical Problem	4
Labelling, Instructions For Use Or Training Problem	3
Detachment Of Device Or Device Component	3
Human Factors Issue	3
Device Issue	3
Application Program Problem	3
Device Handling Problem	3
Unintended Movement	3
Detachment Of Device Component	3
Table	3
Device Operational Issue	3
Component Missing	3
Electrical /Electronic Property Problem	3
Misassembled	2
Component Misassembled	2
Fail-Safe Problem	2
Inadequate Instructions For Healthcare Professional	2
Human-Device Interface Problem	2
Programming Issue	2
Fracture	2
Unexpected Therapeutic Results	2
Loss Of Data	2
Operating System Version Or Upgrade Problem	2
Protective Measures Problem	2
Misassembly By Users	2
Insufficient Information	2
Display Or Visual Feedback Problem	2
Thermal Decomposition Of Device	2
Calibration Error	2
Malposition Of Device	1
Manufacturing, Packaging Or Shipping Problem	1
Moisture Or Humidity Problem	1
Noise, Audible	1
Electrical Overstress	1
Heat Exchanger	1
Break	1
Nonstandard Device	1
Premature Activation	1
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Mechanical Jam	1
Application Network Problem	1
Off-Label Use	1
Fail-Safe Design Failure	1
Diode	1
Cover	1
Device Subassembly	1
Arcing	1
Device-Device Incompatibility	1
Application Interface Becomes Non-Functional Or Program Exits Abnormally	1
Inappropriate Shock	1
Device Stops Intermittently	1
Defective Component	1
Low Readings	1
Failure To Advance	1
Data Problem	1
Power Problem	1
Migration Or Expulsion Of Device	1
Failure To Sense	1
Visual Prompts Will Not Clear	1
Computer System Security Problem	1
Device Component Or Accessory	1
Device Reprocessing Problem	1
Incorrect Measurement	1
Activation, Positioning Or Separation Problem	1
Appropriate Term/Code Not Available	1
Modulator	1
Device Displays Incorrect Message	1
Total Device Problems	423

Recalls
Manufacturer		Recall Class	Date Posted
1	Accuray Incorporated	II	Nov-08-2018
2	Accuray Incorporated	II	Sep-20-2018
3	Accuray Incorporated	II	Dec-26-2017
4	Accuray Incorporated	II	Dec-21-2016
5	Accuray Incorporated	II	Dec-12-2016
6	Accuray Incorporated	II	Feb-09-2016
7	Accuray Incorporated	II	Nov-14-2014
8	Accuray Incorporated	II	Jan-27-2014
9	Brainlab AG	II	Mar-14-2018
10	Brainlab AG	II	Nov-28-2017
11	Brainlab AG	II	Jun-08-2016
12	Brainlab AG	II	Aug-21-2015
13	Brainlab AG	II	Mar-25-2015
14	Brainlab AG	II	Aug-04-2014
15	Brainlab AG	II	Jun-03-2014
16	Brainlab AG	II	Apr-25-2014
17	Civco Medical Instruments Inc	II	Jan-21-2014
18	Elekta Limited	II	Jan-09-2019
19	Elekta Limited	II	Feb-26-2018
20	Elekta, Inc.	II	Feb-08-2019
21	Elekta, Inc.	II	Dec-27-2018
22	Elekta, Inc.	II	Aug-23-2018
23	Elekta, Inc.	II	Aug-17-2018
24	Elekta, Inc.	II	Aug-10-2017
25	Elekta, Inc.	II	Jun-27-2017
26	Elekta, Inc.	II	Dec-09-2016
27	Elekta, Inc.	II	Sep-02-2016
28	Elekta, Inc.	II	Aug-30-2016
29	Elekta, Inc.	II	Jul-27-2016
30	Elekta, Inc.	II	Jun-27-2016
31	Elekta, Inc.	II	May-23-2016
32	Elekta, Inc.	II	Dec-29-2015
33	Elekta, Inc.	II	Dec-17-2015
34	Elekta, Inc.	II	Jul-14-2015
35	Elekta, Inc.	II	Jun-26-2015
36	Elekta, Inc.	II	Feb-10-2015
37	Elekta, Inc.	II	Nov-15-2014
38	Elekta, Inc.	II	Jun-25-2014
39	Elekta, Inc.	II	Jun-17-2014
40	Elekta, Inc.	II	Jun-16-2014
41	Elekta, Inc.	II	Jun-16-2014
42	Elekta, Inc.	II	Apr-02-2014
43	Elekta, Inc.	II	Mar-14-2014
44	Elekta, Inc.	II	Mar-07-2014
45	Elekta, Inc.	II	Mar-06-2014
46	Elekta, Inc.	II	Mar-06-2014
47	Elekta, Inc.	II	Mar-06-2014
48	Elekta, Inc.	II	Feb-20-2014
49	Elekta, Inc.	II	Feb-20-2014
50	Hitachi Ltd., Medical System Operations Group	II	May-01-2018
51	Iba Dosimetry	II	Jun-02-2017
52	Iba Dosimetry Gmbh	II	Jan-21-2016
53	Iba Dosimetry Gmbh	II	Feb-26-2015
54	Iba Dosimetry Gmbh	II	Nov-04-2014
55	Ion Beam Applications S.A.	II	Oct-29-2014
56	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK	II	Mar-31-2016
57	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK	II	Mar-24-2016
58	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK	II	May-01-2015
59	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK	II	Dec-17-2014
60	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK	II	Sep-16-2014
61	Mobius Medical Systems, LP	II	May-16-2017
62	PTW-Freiburg	II	Aug-21-2015
63	Philips Medical Systems	II	Feb-02-2016
64	Siemens Medical Solutions USA, Inc	II	Apr-17-2018
65	Siemens Medical Solutions USA, Inc	II	Mar-20-2017
66	Siemens Medical Solutions USA, Inc	II	Mar-09-2017
67	Siemens Medical Solutions USA, Inc	II	Feb-16-2017
68	Siemens Medical Solutions USA, Inc	II	Sep-23-2016
69	Siemens Medical Solutions USA, Inc	II	Oct-27-2015
70	Siemens Medical Solutions USA, Inc	II	Oct-06-2015
71	Siemens Medical Solutions USA, Inc	II	Sep-24-2015
72	Siemens Medical Solutions USA, Inc	II	Mar-18-2015
73	Siemens Medical Solutions USA, Inc	II	Mar-16-2015
74	Siemens Medical Solutions USA, Inc	II	Feb-05-2015
75	Siemens Medical Solutions USA, Inc	II	Jan-26-2015
76	Siemens Medical Solutions USA, Inc	II	Jan-15-2015
77	Siemens Medical Solutions USA, Inc	II	Aug-10-2014
78	Siemens Medical Solutions USA, Inc	II	Aug-10-2014
79	Siemens Medical Solutions USA, Inc	II	Jun-20-2014
80	Siemens Medical Solutions USA, Inc	II	May-23-2014
81	Siemens Medical Solutions USA, Inc	II	May-21-2014
82	Sun Nuclear Corporation	II	Jan-13-2015
83	TomoTherapy Incorporated	II	Dec-12-2014
84	TomoTherapy Incorporated	II	Aug-15-2014
85	TomoTherapy Incorporated	II	Aug-15-2014
86	Varian Medical Systems	II	Oct-01-2018
87	Varian Medical Systems, Inc.	II	Jan-10-2017
88	Varian Medical Systems, Inc.	II	Oct-13-2016
89	Varian Medical Systems, Inc.	II	Jul-11-2016
90	Varian Medical Systems, Inc.	II	Dec-16-2014
91	Varian Medical Systems, Inc.	II	Sep-13-2014
92	Varian Medical Systems, Inc.	II	Apr-24-2014
93	Varian Medical Systems, Inc. Oncology Systems	II	Jun-26-2015
94	Viewray Incorporated	II	Mar-31-2016
95	Viewray Incorporated	II	Feb-12-2016
96	Viewray Incorporated	II	Oct-09-2015
97	Viewray Incorporated	II	Jul-16-2015
98	Viewray Incorporated	II	Jul-02-2015
99	Viewray Incorporated	II	May-05-2015
100	Vision RT Ltd	II	Oct-03-2018
101	Vision RT Ltd	II	Aug-25-2016
102	Vision Rt Inc	II	Jan-07-2015
103	Vision Rt Inc	II	Dec-16-2014
104	Wfr/aquaplast Corp	II	Mar-25-2016

TPLC Last Update: 2019-04-02 21:04:18