System, Planning, Radiation Therapy Treatment

Device Code: 5396

Product Code(s): MUJ

Device Classification Information

• Device Type ID: 5396
• Device Name: System, Planning, Radiation Therapy Treatment
• 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: MUJ
• 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
• 12-255 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

Total Product Life Cycle

• Device Type ID: 5396
• Device: System, Planning, Radiation Therapy Treatment
• Product Code: MUJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Medical Charged-particle Radiation Therapy System.
• CFR Regulation Number: 892.5050 [🔎]

Premarket Reviews
Manufacturer	Decision
.DECIMAL LLC.
	SUBSTANTIALLY EQUIVALENT	1
ACCURAY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
BEST MEDICAL INTERNA
	SUBSTANTIALLY EQUIVALENT	1
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	2
ECKERT & ZIEGLER BEBIG GMBH
	SUBSTANTIALLY EQUIVALENT	1
ELEKTA AB
	SUBSTANTIALLY EQUIVALENT	3
ELEKTA INC
	SUBSTANTIALLY EQUIVALENT	1
ELEKTA INSTRUMENT AB
	SUBSTANTIALLY EQUIVALENT	1
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
	SUBSTANTIALLY EQUIVALENT	3
IMPAC
	SUBSTANTIALLY EQUIVALENT	1
MEDCOM GMBH
	SUBSTANTIALLY EQUIVALENT	1
NUCLETRON
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	2
PROWESS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAYSEARCH LABORATORIES AB
	SUBSTANTIALLY EQUIVALENT	2
RAYSEARCH LABORATORIES AB (PUBL)
	SUBSTANTIALLY EQUIVALENT	4
SIEMENS
	SUBSTANTIALLY EQUIVALENT	4
SIEMENS CAPITAL
	SUBSTANTIALLY EQUIVALENT	4
VARIAN
	SUBSTANTIALLY EQUIVALENT	8
VARIAN MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	8

Device Problems
Computer Software Problem	52
Adverse Event Without Identified Device Or Use Problem	7
Device Operates Differently Than Expected	3
Improper Or Incorrect Procedure Or Method	2
Application Program Problem: Dose Calculation Error	2
Use Of Device Problem	1
Appropriate Term/Code Not Available	1
Device Operational Issue	1
Programming Issue	1
Application Program Problem	1
Total Device Problems	71

Recalls
Manufacturer		Recall Class	Date Posted
1	Accuray Incorporated	II	Jun-26-2015
2	Brainlab AG	II	Jan-14-2016
3	Brainlab AG	II	Jan-15-2015
4	Elekta Inc	II	Dec-13-2017
5	Elekta, Inc.	II	Feb-27-2019
6	Elekta, Inc.	II	Jan-18-2017
7	Elekta, Inc.	II	Jan-11-2017
8	Elekta, Inc.	II	Jan-10-2017
9	Elekta, Inc.	II	Nov-28-2016
10	Elekta, Inc.	II	Nov-25-2016
11	Elekta, Inc.	II	Oct-13-2016
12	Elekta, Inc.	II	Sep-01-2016
13	Elekta, Inc.	II	Jun-02-2016
14	Elekta, Inc.	II	Jan-07-2016
15	Elekta, Inc.	II	Oct-30-2015
16	Elekta, Inc.	II	Oct-16-2015
17	Elekta, Inc.	II	Oct-07-2015
18	Elekta, Inc.	II	Jun-26-2015
19	Elekta, Inc.	II	Jun-04-2015
20	Elekta, Inc.	II	Mar-04-2015
21	Elekta, Inc.	II	Mar-02-2015
22	Elekta, Inc.	II	Sep-04-2014
23	Elekta, Inc.	II	Sep-03-2014
24	Elekta, Inc.	II	Mar-13-2014
25	Elekta, Inc.	II	Feb-04-2014
26	Elekta, Inc.	II	Jan-17-2014
27	Mevion Medical Systems, Inc.	II	Nov-15-2016
28	Mevion Medical Systems, Inc.	II	Nov-15-2016
29	Mevion Medical Systems, Inc.	II	Nov-15-2016
30	Nucletron BV	II	Oct-26-2017
31	Philips Medical Systems (Cleveland), Inc.	II	Mar-31-2014
32	Philips Medical Systems, Inc.	II	May-21-2015
33	RAYSEARCH LABORATORIES AB	II	Oct-30-2018
34	RAYSEARCH LABORATORIES AB	II	Jul-26-2018
35	RAYSEARCH LABORATORIES AB	II	Jul-19-2018
36	RAYSEARCH LABORATORIES AB	II	Jun-26-2018
37	RAYSEARCH LABORATORIES AB	II	Mar-29-2018
38	RAYSEARCH LABORATORIES AB	II	Jan-17-2018
39	RAYSEARCH LABORATORIES AB	II	Apr-12-2017
40	RAYSEARCH LABORATORIES AB	II	Dec-08-2016
41	RAYSEARCH LABORATORIES AB	II	Dec-07-2016
42	RAYSEARCH LABORATORIES AB	II	Oct-13-2016
43	RAYSEARCH LABORATORIES AB	II	Oct-04-2016
44	RAYSEARCH LABORATORIES AB	II	Jul-15-2016
45	RAYSEARCH LABORATORIES AB	II	May-25-2016
46	RAYSEARCH LABORATORIES AB	II	Sep-17-2015
47	RAYSEARCH LABORATORIES AB	II	Aug-25-2015
48	RAYSEARCH LABORATORIES AB	II	May-27-2015
49	RAYSEARCH LABORATORIES AB	II	Mar-20-2015
50	RAYSEARCH LABORATORIES AB	II	Jun-17-2014
51	RAYSEARCH LABORATORIES AB	II	Apr-21-2014
52	RAYSEARCH LABORATORIES AB	II	Mar-31-2014
53	RAYSEARCH LABORATORIES AB	II	Mar-28-2014
54	Siemens Medical Solutions USA, Inc	II	Jul-17-2014
55	Varian Medical Systems, Inc.	II	Jan-24-2019
56	Varian Medical Systems, Inc.	II	Feb-12-2016
57	Varian Medical Systems, Inc.	II	Oct-30-2015
58	Varian Medical Systems, Inc.	II	Sep-16-2014

TPLC Last Update: 2019-04-02 21:05:30