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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accelerator, linear, medical
Regulation Description Medical charged-particle radiation therapy system.
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY, INC.
  SUBSTANTIALLY EQUIVALENT 4
ADAC
  SUBSTANTIALLY EQUIVALENT 6
BIONX
  SUBSTANTIALLY EQUIVALENT 9
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 13
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CIVCO
  SUBSTANTIALLY EQUIVALENT 2
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
Elekta Instrument AB
  SUBSTANTIALLY EQUIVALENT 16
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
HUESTIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMPAC
  SUBSTANTIALLY EQUIVALENT 7
LEIBINGER
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC
  SUBSTANTIALLY EQUIVALENT 3
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 5
NOMOS
  SUBSTANTIALLY EQUIVALENT 12
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 11
RADIATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
RADIONICS, INC
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 15
STANDARD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
TomoTherapy
  SUBSTANTIALLY EQUIVALENT 2
VARIAN
  SUBSTANTIALLY EQUIVALENT 35

Device Problems
Computer software issue 4
Detachment of device component 2
Application interface becomes non-functional or program exits abnormally 1
No display or display failure 1
Instruction for use issue 1
Incorrect or inadequate result 1
Total Device Problems 10

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 13 25 15 12 60 33 8
Class III 1 2 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Inc II Jan-18-2011
2 Accuray Inc II Dec-16-2010
3 Accuray Inc II Sep-14-2009
4 Accuray Inc II Jan-17-2009
5 Accuray Inc II Sep-17-2008
6 Accuray Inc II Sep-16-2008
7 Accuray Incorporated II Apr-16-2013
8 Accuray Incorporated II Feb-23-2012
9 Accuray Incorporated II Jan-11-2012
10 Accuray Incorporated II Oct-11-2011
11 Brainlab AG II Jul-02-2009
12 Civco Medical Instruments Inc II Sep-18-2008
13 Civco Medical Instruments Inc III May-21-2008
14 Elekta, Inc. II Mar-10-2013
15 Elekta, Inc. II Oct-30-2012
16 Elekta, Inc. II Sep-19-2012
17 Elekta, Inc. II Sep-10-2012
18 Elekta, Inc. II May-23-2012
19 Elekta, Inc. II Feb-21-2012
20 Elekta, Inc. II Dec-01-2011
21 Elekta, Inc. II Dec-01-2011
22 Elekta, Inc. II Nov-29-2011
23 Elekta, Inc. II Mar-22-2011
24 Elekta, Inc. II Mar-04-2011
25 Elekta, Inc. II Feb-15-2011
26 Elekta, Inc. II Dec-03-2010
27 Elekta, Inc. II Apr-27-2010
28 Elekta, Inc. II Apr-26-2010
29 Elekta, Inc. II Apr-22-2010
30 Elekta, Inc. II Apr-16-2010
31 Elekta, Inc. II Mar-18-2010
32 Elekta, Inc. III Feb-07-2007
33 Impac Medical Systems Inc II Jul-06-2012
34 Impac Medical Systems Inc II Oct-17-2011
35 Impac Medical Systems Inc II Jun-24-2011
36 Impac Medical Systems Inc II Feb-04-2011
37 Impac Medical Systems Inc II Oct-18-2010
38 Impac Medical Systems Inc II Aug-21-2009
39 Impac Medical Systems Inc II Aug-16-2008
40 Integra LifeSciences Corp II Mar-08-2012
41 Med Tec Inc III Nov-06-2009
42 Med Tec Inc dba CIVCO Medical Solutions III May-21-2008
43 Northwest Medical Physics Equipment Inc II Aug-09-2007
44 Northwest Medical Physics Equipment Inc II Aug-08-2007
45 Northwest Medical Physics Equipment Inc II Aug-08-2007
46 Northwest Medical Physics Equipment Inc II Aug-08-2007
47 Northwest Medical Physics Equipment Inc II Aug-08-2007
48 Northwest Medical Physics Equipment Inc II Aug-08-2007
49 Northwest Medical Physics Equipment Inc II Aug-08-2007
50 Siemens Medical Solutions USA, Inc II Apr-26-2013
51 Siemens Medical Solutions USA, Inc II Apr-10-2013
52 Siemens Medical Solutions USA, Inc II Apr-02-2013
53 Siemens Medical Solutions USA, Inc II Mar-05-2013
54 Siemens Medical Solutions USA, Inc II Jul-24-2012
55 Siemens Medical Solutions USA, Inc II May-08-2012
56 Siemens Medical Solutions USA, Inc II May-07-2012
57 Siemens Medical Solutions USA, Inc II May-03-2012
58 Siemens Medical Solutions USA, Inc II Mar-21-2012
59 Siemens Medical Solutions USA, Inc II Feb-23-2012
60 Siemens Medical Solutions USA, Inc II Jan-17-2012
61 Siemens Medical Solutions USA, Inc II Jan-11-2012
62 Siemens Medical Solutions USA, Inc II Jan-11-2012
63 Siemens Medical Solutions USA, Inc II Aug-11-2011
64 Siemens Medical Solutions USA, Inc II Aug-10-2011
65 Siemens Medical Solutions USA, Inc II Jul-11-2011
66 Siemens Medical Solutions USA, Inc II Jun-02-2011
67 Siemens Medical Solutions USA, Inc II May-23-2011
68 Siemens Medical Solutions USA, Inc II May-19-2011
69 Siemens Medical Solutions USA, Inc II May-12-2011
70 Siemens Medical Solutions USA, Inc II Apr-15-2011
71 Siemens Medical Solutions USA, Inc II Apr-13-2011
72 Siemens Medical Solutions USA, Inc II Mar-07-2011
73 Siemens Medical Solutions USA, Inc II Mar-04-2011
74 Siemens Medical Solutions USA, Inc II Feb-08-2011
75 Siemens Medical Solutions USA, Inc II Nov-24-2010
76 Siemens Medical Solutions USA, Inc II Nov-05-2009
77 Siemens Medical Solutions USA, Inc II Sep-24-2009
78 Siemens Medical Solutions USA, Inc II Jan-30-2009
79 Siemens Medical Solutions USA, Inc II Jan-29-2009
80 Siemens Medical Solutions USA, Inc II Jan-14-2009
81 Siemens Medical Solutions USA, Inc II Oct-20-2008
82 Siemens Medical Solutions USA, Inc II Oct-16-2008
83 Siemens Medical Solutions USA, Inc II Sep-29-2008
84 Siemens Medical Solutions USA, Inc II Sep-17-2008
85 Siemens Medical Solutions USA, Inc II Sep-04-2008
86 Siemens Medical Solutions USA, Inc II Aug-20-2008
87 Siemens Medical Solutions USA, Inc II Apr-30-2008
88 Siemens Medical Solutions USA, Inc II Apr-02-2008
89 Siemens Medical Solutions USA, Inc II Feb-19-2008
90 Siemens Medical Solutions USA, Inc II Feb-14-2008
91 Siemens Medical Solutions USA, Inc II Dec-01-2007
92 Siemens Medical Solutions USA, Inc II Nov-09-2007
93 Siemens Medical Solutions USA, Inc - Radiation Oncology II Jun-23-2011
94 Siemens Medical Solutions USA, Inc., Concord, CA II Feb-24-2011
95 Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510 II Jan-18-2011
96 TomoTherapy Incorporated II Jan-22-2009
97 TomoTherapy Incorporated II Jan-05-2009
98 TomoTherapy Incorporated II Aug-24-2008
99 Varian Medical Systems Inc II Feb-15-2008
100 Varian Medical Systems Inc II Feb-14-2008
101 Varian Medical Systems Inc II Jan-29-2008
102 Varian Medical Systems Inc II Aug-29-2007
103 Varian Medical Systems Inc II Jul-12-2007
104 Varian Medical Systems Inc II Jun-28-2007
105 Varian Medical Systems Inc. II Dec-28-2010
106 Varian Medical Systems Oncology Systems II Feb-15-2011
107 Varian Medical Systems Oncology Systems II Feb-01-2011
108 Varian Medical Systems Oncology Systems II Jan-31-2011
109 Varian Medical Systems Oncology Systems II Jan-18-2011
110 Varian Medical Systems Oncology Systems II Jan-10-2011
111 Varian Medical Systems Oncology Systems II Jan-10-2011
112 Varian Medical Systems Oncology Systems II Dec-29-2010
113 Varian Medical Systems Oncology Systems II Oct-20-2010
114 Varian Medical Systems Oncology Systems II Nov-09-2009
115 Varian Medical Systems Oncology Systems II Aug-27-2009
116 Varian Medical Systems Oncology Systems II Aug-27-2009
117 Varian Medical Systems Oncology Systems II Feb-20-2009
118 Varian Medical Systems Oncology Systems II Oct-22-2008
119 Varian Medical Systems Oncology Systems II Oct-20-2008
120 Varian Medical Systems Oncology Systems II Sep-17-2008
121 Varian Medical Systems Oncology Systems II Sep-16-2008
122 Varian Medical Systems Oncology Systems II Sep-04-2008
123 Varian Medical Systems Oncology Systems II Aug-15-2008
124 Varian Medical Systems Oncology Systems II Aug-02-2008
125 Varian Medical Systems Oncology Systems II Jun-06-2007
126 Varian Medical Systems, Inc. II Sep-14-2011
127 Varian Medical Systems, Inc. Oncology Systems II May-15-2013
128 Varian Medical Systems, Inc. Oncology Systems II Apr-23-2013
129 Varian Medical Systems, Inc. Oncology Systems II Dec-17-2012
130 Varian Medical Systems, Inc. Oncology Systems II Nov-01-2012
131 Varian Medical Systems, Inc. Oncology Systems II Sep-14-2012
132 Varian Medical Systems, Inc. Oncology Systems II Aug-08-2012
133 Varian Medical Systems, Inc. Oncology Systems II May-16-2012
134 Varian Medical Systems, Inc. Oncology Systems II May-08-2012
135 Varian Medical Systems, Inc. Oncology Systems II Mar-16-2012
136 Varian Medical Systems, Inc. Oncology Systems II Mar-06-2012
137 Varian Medical Systems, Inc. Oncology Systems II Feb-23-2012
138 Varian Medical Systems, Inc. Oncology Systems II Feb-03-2012
139 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
140 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
141 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
142 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
143 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
144 Varian Medical Systems, Inc. Oncology Systems II Dec-02-2011
145 Varian Medical Systems, Inc. Oncology Systems II Dec-01-2011
146 Varian Medical Systems, Inc. Oncology Systems II Nov-09-2011
147 Varian Medical Systems, Inc. Oncology Systems II Sep-14-2011
148 Varian Medical Systems, Inc. Oncology Systems II Aug-31-2011
149 Varian Medical Systems, Inc. Oncology Systems II Aug-31-2011
150 Varian Medical Systems, Inc. Oncology Systems II Aug-31-2011
151 Varian Medical Systems, Inc. Oncology Systems II Aug-30-2011
152 Varian Medical Systems, Inc. Oncology Systems II Aug-22-2011
153 Varian Medical Systems, Inc. Oncology Systems II Aug-10-2011
154 Varian Medical Systems, Inc. Oncology Systems II Jul-28-2011
155 Varian Medical Systems, Inc. Oncology Systems II Jul-11-2011
156 Varian Medical Systems, Inc. Oncology Systems II Jul-08-2011
157 Varian Medical Systems, Inc. Oncology Systems II Jul-08-2011
158 Varian Medical Systems, Inc. Oncology Systems II Jul-08-2011
159 Varian Medical Systems, Inc. Oncology Systems II May-20-2011
160 Varian Medical Systems, Inc. Oncology Systems II May-16-2011
161 Varian Medical Systems, Inc. Oncology Systems II May-13-2011
162 Varian Medical Systems, Inc. Oncology Systems II May-10-2011
163 Varian Medical Systems, Inc. Oncology Systems II May-10-2011
164 Varian Medical Systems, Inc. Oncology Systems II May-02-2011
165 Varian Medical Systems, Inc. Oncology Systems II Apr-29-2011
166 Varian Medical Systems, Inc. Oncology Systems II Apr-25-2011
167 Varian Medical Systems, Inc. Oncology Systems II Apr-12-2011
168 Varian Medical Systems, Inc. Oncology Systems II Apr-07-2011
169 Varian Medical Systems, Inc. Oncology Systems II Feb-08-2011
170 Varian Medical Systems, Inc. Oncology Systems II Jan-21-2011

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