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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, image processing, radiological
Regulation Description Picture archiving and communications system.
Product CodeLLZ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
A.L.I. TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUSON
  SUBSTANTIALLY EQUIVALENT 2
ADAC
  SUBSTANTIALLY EQUIVALENT 14
AGFA COMPANY
  SUBSTANTIALLY EQUIVALENT 6
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
APPLICARE MEDICAL IMAGING, B.V.
  SUBSTANTIALLY EQUIVALENT 1
ASPYRA
  SUBSTANTIALLY EQUIVALENT 1
BIOTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 7
CAMTRONICS
  SUBSTANTIALLY EQUIVALENT 1
CANON
  SUBSTANTIALLY EQUIVALENT 1
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 3
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPUTER PROGRAMS AND SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CTI PET SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 13
EMAGEON
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 19
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 53
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 11
iCAD Inc.
  SUBSTANTIALLY EQUIVALENT 1
IDX SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
IMPAC
  SUBSTANTIALLY EQUIVALENT 2
Intelerad Medical Systems Inc.
  SUBSTANTIALLY EQUIVALENT 2
INVIVO
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 8
MCKESSON
  SUBSTANTIALLY EQUIVALENT 3
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NICOLET BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
Pathfinder Therapeutics, Inc.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 28
RIVERAIN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 77
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 12
TROPHY
  SUBSTANTIALLY EQUIVALENT 3
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 25
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Programming issue 230
Computer software issue 62
Data Issue 55
Device operates differently than expected 48
Patient Data Issue 32
Device Issue 24
Loss of Data 17
No Known Device Problem 13
Computer operating system issue 11
Incorrect measurement 9
Device inoperable 7
No display or display failure 7
Image display error 6
Failure to power-up 4
Application program issue 4
Device displays error message 4
Smoking 3
Incorrect or inadequate result 3
Image orientation incorrect 3
Poor quality image 3
Incorrect display 3
Failure to back-up 2
Nonstandard device or device component 2
Image reversal 2
Use of Device Issue 2
Fitting problem 2
Incorrect software programming calculations 2
Overheating of device or device component 2
Difficult to position 2
Structural problem 2
Malposition of device 2
Data back-up problem 2
No code available 2
Operating system becomes non-functional 1
Problem with software installation 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Incorrect error code 1
Device handling issue 1
Missing test results 1
Mislocation 1
Failure to transmit record 1
User used incorrect product for intended use 1
Other (for use when an appropriate device code cannot be identified) 1
Malfunction 1
Incorrect or inadequate test results 1
Improper or incorrect procedure or method 1
Size incorrect for patient 1
Slippage of device or device component 1
Application interface becomes non-functional or program exits abnormally 1
Erratic display 1
Device emits odor 1
No device output 1
Blank screen 1
Break 1
Burn of device or device component 1
Entrapment of device or device component 1
False positive result 1
Fracture 1
Material fragmentation 1
Total Device Problems 599

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 3 0 0 0 0
Class II 7 27 21 13 27 27 27 25 18 12
Class III 1 2 1 2 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II May-27-2014
2 AGFA Corp. II Feb-03-2014
3 AGFA Corp. II Oct-21-2013
4 AGFA Corp. II Apr-08-2013
5 AGFA Corp. II Apr-08-2013
6 AGFA Corp. II Aug-22-2012
7 AGFA Corp. II Aug-10-2012
8 AGFA Corp. II Jul-24-2012
9 AGFA Corp. II Nov-23-2011
10 AGFA Corp. II Nov-18-2011
11 AGFA Corp. II Nov-18-2011
12 AGFA Corp. II Jun-10-2011
13 AGFA Corp. II May-24-2011
14 AGFA Corp. II Mar-16-2011
15 AGFA Corp. II Feb-25-2011
16 AGFA Corp. II Feb-24-2011
17 AGFA Corp. III Dec-29-2010
18 AGFA Corp. II Jul-29-2010
19 AGFA Corp. III Jun-11-2010
20 AGFA Corp. III Nov-18-2009
21 AGFA Corp. II Sep-08-2009
22 AGFA Corp. II Sep-02-2009
23 AGFA Corp. II Feb-03-2009
24 AGFA Corp. II Sep-11-2008
25 AGFA Corp. II Sep-11-2008
26 AGFA Corp. III Sep-04-2008
27 AGFA Corp. II Jul-02-2008
28 AGFA Corp. II Jun-27-2008
29 AGFA Corp. II Jun-27-2008
30 AGFA Corp. II Mar-31-2008
31 AGFA Healthcare Corp. II Nov-17-2015
32 AGFA Healthcare Corp. II Jul-13-2015
33 Brainlab AG II Nov-05-2015
34 Brainlab AG II Jul-30-2014
35 Carestream Health Inc II May-02-2016
36 Carestream Health Inc. II Nov-13-2013
37 Carestream Health, Inc. II Dec-17-2014
38 Cerner Corp II Sep-25-2007
39 Digisonics, Inc II May-13-2011
40 Digisonics, Inc II May-10-2011
41 Digisonics, Inc II May-10-2011
42 Digisonics, Inc II Apr-29-2011
43 EOS Imaging II Dec-26-2013
44 Emageon III May-28-2008
45 Eos Imaging II Jun-28-2011
46 Fujifilm Medical Systems U.S.A., Inc. II Jun-21-2016
47 GE Healthcare II Nov-05-2015
48 GE Healthcare II Oct-05-2015
49 GE Healthcare II Aug-27-2015
50 GE Healthcare II Feb-26-2015
51 GE Healthcare II May-28-2014
52 GE Healthcare II Sep-20-2008
53 GE Healthcare II Nov-28-2007
54 GE Healthcare Integrated IT Solutions II Nov-24-2009
55 GE Healthcare Integrated IT Solutions II Jul-13-2009
56 GE Healthcare Integrated IT Solutions II Jul-01-2009
57 GE Healthcare Integrated IT Solutions II Feb-03-2009
58 GE Healthcare Integrated IT Solutions II Feb-03-2009
59 GE Healthcare Integrated IT Solutions II Jan-27-2009
60 GE Healthcare Integrated IT Solutions II Jan-23-2009
61 GE Healthcare Integrated IT Solutions II Dec-13-2008
62 GE Healthcare Integrated IT Solutions II Sep-16-2008
63 GE Healthcare Integrated IT Solutions II Sep-02-2008
64 GE Healthcare Integrated IT Solutions II Sep-02-2008
65 GE Healthcare Integrated IT Solutions II May-01-2008
66 GE Healthcare Integrated IT Solutions II Jan-25-2007
67 GE Healthcare It II Jan-14-2014
68 GE Healthcare It II Oct-30-2013
69 GE Healthcare It II Oct-21-2013
70 GE Healthcare, LLC II Apr-25-2014
71 GE Healthcare, LLC II Nov-13-2013
72 GE Healthcare, LLC II Sep-19-2013
73 GE Healthcare, LLC II Sep-18-2013
74 GE Healthcare, LLC II Aug-27-2013
75 GE Healthcare, LLC II Apr-23-2013
76 GE Healthcare, LLC II Apr-17-2013
77 GE Healthcare, LLC II Dec-19-2012
78 GE Healthcare, LLC II Oct-24-2012
79 GE Healthcare, LLC II Oct-19-2012
80 GE Healthcare, LLC II Aug-13-2012
81 GE Healthcare, LLC II Jul-09-2012
82 GE Healthcare, LLC II Jan-11-2012
83 GE Healthcare, LLC II Sep-27-2011
84 GE Healthcare, LLC II Aug-12-2011
85 GE Healthcare, LLC II Feb-15-2011
86 GE Healthcare, LLC II Dec-03-2010
87 GE Healthcare, LLC II Nov-26-2010
88 GE OEC Medical Systems, Inc II Dec-17-2013
89 GE OEC Medical Systems, Inc I Aug-28-2012
90 GE OEC Medical Systems, Inc II Aug-22-2012
91 GE OEC Medical Systems, Inc I Aug-08-2012
92 GE OEC Medical Systems, Inc I Jul-12-2012
93 GE OEC Medical Systems, Inc II Apr-11-2011
94 GE OEC Medical Systems, Inc II Jan-23-2008
95 GE OEC Medical Systems, Inc II Nov-10-2007
96 GE OEC Medical Systems, Inc III Aug-07-2007
97 GE OEC Medical Systems,Inc II Mar-30-2007
98 Ge Healthcare It II Jan-15-2014
99 Ge Healthcare It II Jan-14-2014
100 Ge Healthcare It II Oct-30-2013
101 Ge Healthcare It II Apr-16-2010
102 Ge Healthcare It II Apr-15-2010
103 Ge Healthcare, Llc II Jun-02-2010
104 Hologic, Inc. II Apr-05-2012
105 IMTEC IMAGING L.L.C. II Sep-22-2009
106 Imaging Sciences International, LLC II Sep-26-2012
107 Intelerad Medical Systems II Aug-19-2014
108 Intelerad Medical Systems Inc. II Aug-27-2009
109 Intio Inc II Mar-20-2013
110 MIMvista Corp II Sep-03-2008
111 Mckesson Information Solutions LLC II Feb-12-2014
112 Mckesson Information Solutions LLC II Dec-20-2013
113 Mckesson Information Solutions LLC II Sep-30-2013
114 Mckesson Information Solutions LLC II Aug-18-2011
115 Mckesson Medical Imaging Group II Aug-22-2012
116 Mckesson Medical Immaging II Mar-17-2016
117 Mckesson Medical Immaging II Jul-28-2014
118 Mckesson Medical Immaging II Jun-06-2014
119 Mckesson Medical Immaging II May-13-2014
120 Mckesson Medical Immaging II May-28-2010
121 Medtronic Navigation, Inc. II Jul-13-2010
122 Merge Healthcare, Inc. II Feb-10-2016
123 Merge Healthcare, Inc. II Dec-28-2015
124 Merge Healthcare, Inc. II Oct-15-2014
125 Novarad Corporation II May-06-2016
126 Philips Healthcare Inc. II Oct-07-2011
127 Philips Healthcare Inc. II Sep-14-2011
128 Philips Healthcare Informatics, Inc. II Aug-16-2014
129 Philips Healthcare Informatics, Inc. II Nov-13-2013
130 Philips Healthcare Informatics, Inc. II Jan-30-2009
131 Philips Healthcare Informatics, Inc. II Oct-28-2008
132 Philips Healthcare Informatics, Inc. II Sep-18-2008
133 Philips Healthcare Informatics, Inc. II Aug-16-2008
134 Philips Healthcare Informatics, Inc. II May-08-2008
135 Philips Medical Systems II Nov-10-2011
136 Philips Medical Systems North America Co. Phillips II Feb-04-2011
137 Philips Medical Systems North America Co. Phillips II Nov-18-2010
138 Philips Medical Systems North America Co. Phillips II Sep-16-2008
139 Philips Medical Systems, Inc. II Apr-24-2014
140 Philips Ultrasound, Inc. II Jun-15-2015
141 Philips Ultrasound, Inc. II Dec-16-2014
142 Philips Ultrasound, Inc. II Jul-23-2014
143 Siemens Medical Solutions USA, Inc II May-04-2016
144 Siemens Medical Solutions USA, Inc II Apr-07-2016
145 Siemens Medical Solutions USA, Inc II Mar-23-2016
146 Siemens Medical Solutions USA, Inc II Mar-17-2016
147 Siemens Medical Solutions USA, Inc II Feb-23-2016
148 Siemens Medical Solutions USA, Inc II Feb-19-2016
149 Siemens Medical Solutions USA, Inc II Jan-06-2016
150 Siemens Medical Solutions USA, Inc II Dec-24-2015
151 Siemens Medical Solutions USA, Inc II Nov-20-2015
152 Siemens Medical Solutions USA, Inc II Sep-02-2015
153 Siemens Medical Solutions USA, Inc II Jul-02-2015
154 Siemens Medical Solutions USA, Inc II Jun-03-2015
155 Siemens Medical Solutions USA, Inc II Mar-30-2015
156 Siemens Medical Solutions USA, Inc II Jan-28-2015
157 Siemens Medical Solutions USA, Inc II Dec-15-2014
158 Siemens Medical Solutions USA, Inc II Jul-23-2014
159 Siemens Medical Solutions USA, Inc II May-16-2014
160 Siemens Medical Solutions USA, Inc II May-13-2014
161 Siemens Medical Solutions USA, Inc II Mar-18-2014
162 Siemens Medical Solutions USA, Inc II Nov-13-2013
163 Siemens Medical Solutions USA, Inc II Aug-15-2013
164 Siemens Medical Solutions USA, Inc II Aug-01-2013
165 Siemens Medical Solutions USA, Inc II Apr-12-2013
166 Siemens Medical Solutions USA, Inc II Dec-03-2012
167 Siemens Medical Solutions USA, Inc II Oct-11-2012
168 Siemens Medical Solutions USA, Inc II Aug-27-2012
169 Siemens Medical Solutions USA, Inc II Aug-24-2012
170 Siemens Medical Solutions USA, Inc II Jul-26-2012
171 Siemens Medical Solutions USA, Inc II Feb-29-2012
172 Siemens Medical Solutions USA, Inc II Feb-20-2012
173 Siemens Medical Solutions USA, Inc II Jan-20-2012
174 Siemens Medical Solutions USA, Inc II Jan-11-2012
175 Siemens Medical Solutions USA, Inc II Jan-11-2012
176 Siemens Medical Solutions USA, Inc II Jan-11-2012
177 Siemens Medical Solutions USA, Inc II Jun-24-2010
178 Siemens Medical Solutions USA, Inc II Apr-20-2010
179 Siemens Medical Solutions USA, Inc II Nov-16-2009
180 Siemens Medical Solutions USA, Inc II Nov-10-2009
181 Siemens Medical Solutions USA, Inc II Jul-07-2009
182 Siemens Medical Solutions USA, Inc II Apr-28-2009
183 Siemens Medical Solutions USA, Inc II Apr-28-2009
184 Siemens Medical Solutions USA, Inc II Jan-08-2009
185 Siemens Medical Solutions USA, Inc II Dec-03-2008
186 Siemens Medical Solutions USA, Inc II Oct-15-2008
187 Siemens Medical Solutions USA, Inc II Aug-24-2008
188 Siemens Medical Solutions USA, Inc II Apr-29-2008
189 Siemens Medical Solutions USA, Inc II Feb-23-2008
190 Siemens Medical Solutions USA, Inc. II May-20-2008
191 Siemens Medical Solutions, USA, Inc II Aug-17-2012
192 Siemens Medical Solutions, USA, Inc II Jul-08-2011
193 Siemens Medical Solutions, USA, Inc II May-25-2011
194 Siemens Medical Solutions, USA, Inc II Jan-02-2009
195 Siemens Medical Solutions, USA, Inc II Sep-29-2008
196 Siemens Medical Solutions, USA, Inc II Mar-28-2007
197 Stentor Inc A Phillips Medical Systems Co. II Mar-13-2007
198 Straumann Manufacturing Inc. II Sep-13-2011
199 Straumann Manufacturing Inc. II Mar-07-2011
200 TeraRecon, Inc. II Feb-09-2015
201 Velocity Medical Solutions, LLC II Mar-25-2014
202 Vital Images, Inc. II Nov-06-2013
203 Vital Images, Inc. II Apr-26-2013
204 Vital Images, Inc. II Apr-18-2013
205 Vital Images, Inc. II Mar-27-2013
206 Vital Images, Inc. II Nov-01-2012
207 Vital Images, Inc. II Jan-11-2012
208 Vital Images, Inc. II Feb-02-2011
209 Vital Images, Inc. II Dec-21-2010
210 Vital Images, Inc. II May-13-2010
211 Vital Images, Inc. II Jan-31-2008
212 Xoran Technologies, Inc. II Jul-09-2009
213 iCAD, Inc. II Mar-04-2015

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