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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system,planning,radiation therapy treatment
Regulation Description Medical charged-particle radiation therapy system.
Product CodeMUJ
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY, INC.
  SUBSTANTIALLY EQUIVALENT 4
ADAC
  SUBSTANTIALLY EQUIVALENT 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 6
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 9
Elekta Instrument AB
  SUBSTANTIALLY EQUIVALENT 4
IMPAC
  SUBSTANTIALLY EQUIVALENT 2
MDS NORDION
  SUBSTANTIALLY EQUIVALENT 3
NOMOS
  SUBSTANTIALLY EQUIVALENT 2
NUCLETRON
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
RADIONICS, INC
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 6
STANDARD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TomoTherapy
  SUBSTANTIALLY EQUIVALENT 4
VARIAN
  SUBSTANTIALLY EQUIVALENT 18

Device Problems
Computer software issue 21
No Known Device Problem 7
Improper or incorrect procedure or method 2
Radiation overexposure 2
Dose calculation error due to software problem 2
Radiation exposure, unintended 2
Unexpected therapeutic results 2
Device operates differently than expected 2
Use of Device Issue 1
Application program issue 1
No code available 1
Total Device Problems 43

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 2 2 4 12 45 14 8 12 15 6
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Inc II Feb-02-2011
2 Accuray Inc II Feb-01-2011
3 Accuray Inc II Jan-10-2011
4 Accuray Inc II Dec-12-2007
5 Accuray Incorporated II Jun-26-2015
6 Accuray Incorporated II Aug-31-2011
7 Brainlab AG II Jan-14-2016
8 Brainlab AG II Jan-15-2015
9 Brainlab AG II Sep-20-2009
10 Brainlab AG II Sep-17-2008
11 Computerized Medical Systems Inc II May-22-2012
12 Computerized Medical Systems Inc II Apr-03-2012
13 Computerized Medical Systems Inc II Aug-03-2011
14 Computerized Medical Systems Inc II Jun-23-2011
15 Computerized Medical Systems Inc II Jun-23-2011
16 Computerized Medical Systems Inc II Jun-20-2011
17 Computerized Medical Systems Inc II Jun-20-2011
18 Computerized Medical Systems Inc II Jun-20-2011
19 Computerized Medical Systems Inc II Jun-20-2011
20 Computerized Medical Systems Inc II Jun-20-2011
21 Computerized Medical Systems Inc II Jun-20-2011
22 Computerized Medical Systems Inc II Jun-20-2011
23 Computerized Medical Systems Inc II Jun-20-2011
24 Computerized Medical Systems Inc II Jun-17-2011
25 Computerized Medical Systems Inc II Jun-16-2011
26 Computerized Medical Systems Inc II Jun-16-2011
27 Computerized Medical Systems Inc II Jun-16-2011
28 Computerized Medical Systems Inc II Jun-15-2011
29 Computerized Medical Systems Inc II Jun-15-2011
30 Computerized Medical Systems Inc II Jun-15-2011
31 Computerized Medical Systems Inc II Jun-15-2011
32 Computerized Medical Systems Inc II Jun-15-2011
33 Computerized Medical Systems Inc II Jun-14-2011
34 Computerized Medical Systems Inc II Jun-14-2011
35 Computerized Medical Systems Inc II Jun-14-2011
36 Computerized Medical Systems Inc II Jun-14-2011
37 Computerized Medical Systems Inc II Jun-14-2011
38 Computerized Medical Systems Inc II Jun-03-2011
39 Computerized Medical Systems Inc II Jun-02-2011
40 Computerized Medical Systems Inc II May-26-2010
41 Computerized Medical Systems Inc II Mar-25-2010
42 Elekta, Inc. II Jun-02-2016
43 Elekta, Inc. II Jan-07-2016
44 Elekta, Inc. II Oct-30-2015
45 Elekta, Inc. II Oct-16-2015
46 Elekta, Inc. II Oct-07-2015
47 Elekta, Inc. II Jun-26-2015
48 Elekta, Inc. II Jun-04-2015
49 Elekta, Inc. II Mar-04-2015
50 Elekta, Inc. II Mar-02-2015
51 Elekta, Inc. II Sep-04-2014
52 Elekta, Inc. II Sep-03-2014
53 Elekta, Inc. II Mar-13-2014
54 Elekta, Inc. II Feb-04-2014
55 Elekta, Inc. II Jan-17-2014
56 Elekta, Inc. II Sep-25-2013
57 Elekta, Inc. II Sep-25-2013
58 Elekta, Inc. II Feb-20-2013
59 Elekta, Inc. II Oct-23-2012
60 Elekta, Inc. II Jul-12-2012
61 Elekta, Inc. II Jul-12-2012
62 Elekta, Inc. II Mar-04-2011
63 Elekta, Inc. II Mar-02-2011
64 Elekta, Inc. II Apr-16-2010
65 Elekta, Inc. II Mar-16-2010
66 Impac Medical Systems Inc II Oct-28-2010
67 Integra LifeSciences Corp. II Apr-12-2013
68 PerMedics, Inc. II Dec-01-2011
69 PerMedics, Inc. II May-18-2010
70 Philips Medical Systems (Cleveland), Inc. II Mar-31-2014
71 Philips Medical Systems, Inc. II May-21-2015
72 Philips Nuclear Medicine, Inc. II Sep-25-2007
73 RAYSEARCH LABORATORIES AB II Jul-15-2016
74 RAYSEARCH LABORATORIES AB II May-25-2016
75 RAYSEARCH LABORATORIES AB II Sep-17-2015
76 RAYSEARCH LABORATORIES AB II Aug-25-2015
77 RAYSEARCH LABORATORIES AB II May-27-2015
78 RAYSEARCH LABORATORIES AB II Mar-20-2015
79 RAYSEARCH LABORATORIES AB II Jun-17-2014
80 RAYSEARCH LABORATORIES AB II Apr-21-2014
81 RAYSEARCH LABORATORIES AB II Mar-31-2014
82 RAYSEARCH LABORATORIES AB II Mar-28-2014
83 RAYSEARCH LABORATORIES AB II Nov-14-2013
84 RAYSEARCH LABORATORIES AB II May-28-2013
85 RAYSEARCH LABORATORIES AB II Sep-24-2012
86 RAYSEARCH LABORATORIES AB II Sep-14-2012
87 RAYSEARCH LABORATORIES AB II Sep-06-2012
88 RAYSEARCH LABORATORIES AB II Mar-26-2012
89 RAYSEARCH LABORATORIES AB II Dec-02-2011
90 Siemens Medical Solutions USA, Inc II Mar-28-2011
91 Siemens Medical Solutions USA, Inc II Jul-17-2014
92 TomoTherapy Incorporated II Mar-14-2011
93 TomoTherapy Incorporated II Dec-27-2010
94 TomoTherapy Incorporated II Aug-12-2010
95 TomoTherapy Incorporated II Aug-02-2010
96 TomoTherapy Incorporated II Jul-22-2010
97 TomoTherapy Incorporated II Sep-21-2009
98 Varian Medical Systems Oncology Systems II Nov-24-2010
99 Varian Medical Systems Oncology Systems II Apr-20-2010
100 Varian Medical Systems Oncology Systems II Sep-22-2009
101 Varian Medical Systems Oncology Systems II Jan-15-2009
102 Varian Medical Systems Oncology Systems II Sep-23-2008
103 Varian Medical Systems, Inc. II Feb-12-2016
104 Varian Medical Systems, Inc. II Oct-30-2015
105 Varian Medical Systems, Inc. II Sep-16-2014
106 Varian Medical Systems, Inc. II Dec-20-2013
107 Varian Medical Systems, Inc. II Aug-31-2011
108 Varian Medical Systems, Inc. Oncology Systems II Feb-20-2013
109 Varian Medical Systems, Inc. Oncology Systems II Sep-26-2012
110 Varian Medical Systems, Inc. Oncology Systems II Jul-19-2012
111 Varian Medical Systems, Inc. Oncology Systems II Mar-06-2012
112 Varian Medical Systems, Inc. Oncology Systems II Jan-13-2012
113 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
114 Varian Medical Systems, Inc. Oncology Systems II Aug-15-2011
115 Varian Medical Systems, Inc. Oncology Systems II Aug-11-2011
116 Varian Medical Systems, Inc. Oncology Systems II Jul-11-2011
117 Varian Medical Systems, Inc. Oncology Systems II Jul-11-2011
118 Varian Medical Systems, Inc. Oncology Systems II Jun-29-2011
119 Varian Medical Systems, Inc. Oncology Systems II May-19-2011
120 Varian Medical Systems, Palo Alto, CA II Jan-18-2011

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