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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 54
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 2
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 78
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 26
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Programming issue 232
Data Issue 86
Computer software issue 81
Device operates differently than expected 55
Patient Data Issue 36
Loss of Data 33
Device Issue 26
No Known Device Problem 16
Device inoperable 14
Computer operating system issue 11
Incorrect measurement 10
Smoking 9
Overheating of device or device component 8
Application program issue 7
No display or display failure 7
Image display error 6
Image orientation incorrect 5
Failure to power-up 4
Device displays error message 4
Patient-device incompatibility 4
Structural problem 3
Use of Device Issue 3
No code available 3
Failure to back-up 3
Poor quality image 3
Incorrect or inadequate result 3
Incorrect display 3
Difficult to position 2
Nonstandard device or device component 2
Positioning Issue 2
Malposition of device 2
Size incorrect for patient 2
Fitting problem 2
Image reversal 2
Data back-up problem 2
Incorrect software programming calculations 2
Missing test results 2
Migration of device or device component 1
Fracture 1
Incorrect error code 1
Human-Device Interface Issue 1
Problem with software installation 1
Operating system becomes non-functional 1
False positive result 1
Improper or incorrect procedure or method 1
Blank screen 1
Application interface becomes non-functional or program exits abnormally 1
Device stops intermittently 1
Improper device output 1
Failure to transmit record 1
Dislodged or dislocated 1
Material fragmentation 1
Device handling issue 1
Installation-related problem 1
User used incorrect product for intended use 1
Device emits odor 1
Erratic display 1
Malfunction 1
Burn of device or device component 1
Entrapment of device or device component 1
Mislocation 1
Incorrect or inadequate test results 1
Break 1
No device output 1
Slippage of device or device component 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 724

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 3 0 0 0 0 0
Class II 7 27 21 13 27 27 27 25 18 53 2
Class III 1 2 1 2 0 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 DICOM GRID INC II Jan-18-2017
40 Digisonics, Inc II May-13-2011
41 Digisonics, Inc II May-10-2011
42 Digisonics, Inc II May-10-2011
43 Digisonics, Inc II Apr-29-2011
44 EOS Imaging II Dec-26-2013
45 Emageon III May-28-2008
46 Eos Imaging II Jun-28-2011
47 Fujifilm Medical Systems U.S.A., Inc. II Oct-12-2016
48 Fujifilm Medical Systems U.S.A., Inc. II Jun-21-2016
49 GE Healthcare II Nov-05-2015
50 GE Healthcare II Oct-05-2015
51 GE Healthcare II Aug-27-2015
52 GE Healthcare II Feb-26-2015
53 GE Healthcare II May-28-2014
54 GE Healthcare II Sep-20-2008
55 GE Healthcare II Nov-28-2007
56 GE Healthcare Integrated IT Solutions II Nov-24-2009
57 GE Healthcare Integrated IT Solutions II Jul-13-2009
58 GE Healthcare Integrated IT Solutions II Jul-01-2009
59 GE Healthcare Integrated IT Solutions II Feb-03-2009
60 GE Healthcare Integrated IT Solutions II Feb-03-2009
61 GE Healthcare Integrated IT Solutions II Jan-27-2009
62 GE Healthcare Integrated IT Solutions II Jan-23-2009
63 GE Healthcare Integrated IT Solutions II Dec-13-2008
64 GE Healthcare Integrated IT Solutions II Sep-16-2008
65 GE Healthcare Integrated IT Solutions II Sep-02-2008
66 GE Healthcare Integrated IT Solutions II Sep-02-2008
67 GE Healthcare Integrated IT Solutions II May-01-2008
68 GE Healthcare Integrated IT Solutions II Jan-25-2007
69 GE Healthcare It II Aug-17-2016
70 GE Healthcare It II Jan-14-2014
71 GE Healthcare It II Oct-30-2013
72 GE Healthcare It II Oct-21-2013
73 GE Healthcare, LLC II Dec-23-2016
74 GE Healthcare, LLC II Apr-25-2014
75 GE Healthcare, LLC II Nov-13-2013
76 GE Healthcare, LLC II Sep-19-2013
77 GE Healthcare, LLC II Sep-18-2013
78 GE Healthcare, LLC II Aug-27-2013
79 GE Healthcare, LLC II Apr-23-2013
80 GE Healthcare, LLC II Apr-17-2013
81 GE Healthcare, LLC II Dec-19-2012
82 GE Healthcare, LLC II Oct-24-2012
83 GE Healthcare, LLC II Oct-19-2012
84 GE Healthcare, LLC II Aug-13-2012
85 GE Healthcare, LLC II Jul-09-2012
86 GE Healthcare, LLC II Jan-11-2012
87 GE Healthcare, LLC II Sep-27-2011
88 GE Healthcare, LLC II Aug-12-2011
89 GE Healthcare, LLC II Feb-15-2011
90 GE Healthcare, LLC II Dec-03-2010
91 GE Healthcare, LLC II Nov-26-2010
92 GE OEC Medical Systems, Inc II Dec-17-2013
93 GE OEC Medical Systems, Inc I Aug-28-2012
94 GE OEC Medical Systems, Inc II Aug-22-2012
95 GE OEC Medical Systems, Inc I Aug-08-2012
96 GE OEC Medical Systems, Inc I Jul-12-2012
97 GE OEC Medical Systems, Inc II Apr-11-2011
98 GE OEC Medical Systems, Inc II Jan-23-2008
99 GE OEC Medical Systems, Inc II Nov-10-2007
100 GE OEC Medical Systems, Inc III Aug-07-2007
101 GE OEC Medical Systems,Inc II Mar-30-2007
102 Ge Healthcare It II Jul-28-2016
103 Ge Healthcare It II Jan-15-2014
104 Ge Healthcare It II Jan-14-2014
105 Ge Healthcare It II Oct-30-2013
106 Ge Healthcare It II Apr-16-2010
107 Ge Healthcare It II Apr-15-2010
108 Ge Healthcare, Llc II Jun-02-2010
109 Hologic, Inc. II Apr-05-2012
110 IMTEC IMAGING L.L.C. II Sep-22-2009
111 Imaging Sciences International, LLC II Sep-26-2012
112 Intelerad Medical Systems II Aug-19-2014
113 Intelerad Medical Systems Inc. II Aug-27-2009
114 Intio Inc II Mar-20-2013
115 MIMvista Corp II Sep-03-2008
116 Mckesson Information Solutions LLC II Feb-12-2014
117 Mckesson Information Solutions LLC II Dec-20-2013
118 Mckesson Information Solutions LLC II Sep-30-2013
119 Mckesson Information Solutions LLC II Aug-18-2011
120 Mckesson Medical Imaging Group II Sep-22-2016
121 Mckesson Medical Imaging Group II Aug-22-2012
122 Mckesson Medical Immaging II Mar-17-2016
123 Mckesson Medical Immaging II Jul-28-2014
124 Mckesson Medical Immaging II Jun-06-2014
125 Mckesson Medical Immaging II May-13-2014
126 Mckesson Medical Immaging II May-28-2010
127 Medtronic Navigation, Inc. II Jul-13-2010
128 Merge Healthcare, Inc. II Jan-19-2017
129 Merge Healthcare, Inc. II Dec-30-2016
130 Merge Healthcare, Inc. II Dec-21-2016
131 Merge Healthcare, Inc. II Dec-09-2016
132 Merge Healthcare, Inc. II Dec-09-2016
133 Merge Healthcare, Inc. II Dec-08-2016
134 Merge Healthcare, Inc. II Dec-05-2016
135 Merge Healthcare, Inc. II Nov-18-2016
136 Merge Healthcare, Inc. II Nov-17-2016
137 Merge Healthcare, Inc. II Nov-17-2016
138 Merge Healthcare, Inc. II Oct-20-2016
139 Merge Healthcare, Inc. II Oct-19-2016
140 Merge Healthcare, Inc. II Oct-18-2016
141 Merge Healthcare, Inc. II Sep-22-2016
142 Merge Healthcare, Inc. II Sep-21-2016
143 Merge Healthcare, Inc. II Sep-14-2016
144 Merge Healthcare, Inc. II Sep-02-2016
145 Merge Healthcare, Inc. II Sep-01-2016
146 Merge Healthcare, Inc. II Aug-29-2016
147 Merge Healthcare, Inc. II Aug-23-2016
148 Merge Healthcare, Inc. II Aug-16-2016
149 Merge Healthcare, Inc. II Aug-12-2016
150 Merge Healthcare, Inc. II Aug-10-2016
151 Merge Healthcare, Inc. II Aug-08-2016
152 Merge Healthcare, Inc. II Jul-29-2016
153 Merge Healthcare, Inc. II Jul-29-2016
154 Merge Healthcare, Inc. II Jul-11-2016
155 Merge Healthcare, Inc. II Jul-08-2016
156 Merge Healthcare, Inc. II Feb-10-2016
157 Merge Healthcare, Inc. II Dec-28-2015
158 Merge Healthcare, Inc. II Oct-15-2014
159 Novarad Corporation II Aug-25-2016
160 Novarad Corporation II Jul-11-2016
161 Novarad Corporation II May-06-2016
162 Philips Electronics North America Corporation II Aug-29-2016
163 Philips Healthcare Inc. II Oct-07-2011
164 Philips Healthcare Inc. II Sep-14-2011
165 Philips Healthcare Informatics, Inc. II Aug-16-2014
166 Philips Healthcare Informatics, Inc. II Nov-13-2013
167 Philips Healthcare Informatics, Inc. II Jan-30-2009
168 Philips Healthcare Informatics, Inc. II Oct-28-2008
169 Philips Healthcare Informatics, Inc. II Sep-18-2008
170 Philips Healthcare Informatics, Inc. II Aug-16-2008
171 Philips Healthcare Informatics, Inc. II May-08-2008
172 Philips Medical Systems II Nov-10-2011
173 Philips Medical Systems North America Co. Phillips II Feb-04-2011
174 Philips Medical Systems North America Co. Phillips II Nov-18-2010
175 Philips Medical Systems North America Co. Phillips II Sep-16-2008
176 Philips Medical Systems, Inc. II Apr-24-2014
177 Philips Ultrasound, Inc. II Jun-15-2015
178 Philips Ultrasound, Inc. II Dec-16-2014
179 Philips Ultrasound, Inc. II Jul-23-2014
180 Siemens Medical Solutions USA, Inc II Sep-27-2016
181 Siemens Medical Solutions USA, Inc II Sep-21-2016
182 Siemens Medical Solutions USA, Inc II Sep-14-2016
183 Siemens Medical Solutions USA, Inc II Jul-20-2016
184 Siemens Medical Solutions USA, Inc II Jun-30-2016
185 Siemens Medical Solutions USA, Inc II Jun-29-2016
186 Siemens Medical Solutions USA, Inc II May-04-2016
187 Siemens Medical Solutions USA, Inc II Apr-07-2016
188 Siemens Medical Solutions USA, Inc II Mar-23-2016
189 Siemens Medical Solutions USA, Inc II Mar-17-2016
190 Siemens Medical Solutions USA, Inc II Feb-23-2016
191 Siemens Medical Solutions USA, Inc II Feb-19-2016
192 Siemens Medical Solutions USA, Inc II Jan-06-2016
193 Siemens Medical Solutions USA, Inc II Dec-24-2015
194 Siemens Medical Solutions USA, Inc II Nov-20-2015
195 Siemens Medical Solutions USA, Inc II Sep-02-2015
196 Siemens Medical Solutions USA, Inc II Jul-02-2015
197 Siemens Medical Solutions USA, Inc II Jun-03-2015
198 Siemens Medical Solutions USA, Inc II Mar-30-2015
199 Siemens Medical Solutions USA, Inc II Jan-28-2015
200 Siemens Medical Solutions USA, Inc II Dec-15-2014
201 Siemens Medical Solutions USA, Inc II Jul-23-2014
202 Siemens Medical Solutions USA, Inc II May-16-2014
203 Siemens Medical Solutions USA, Inc II May-13-2014
204 Siemens Medical Solutions USA, Inc II Mar-18-2014
205 Siemens Medical Solutions USA, Inc II Nov-13-2013
206 Siemens Medical Solutions USA, Inc II Aug-15-2013
207 Siemens Medical Solutions USA, Inc II Aug-01-2013
208 Siemens Medical Solutions USA, Inc II Apr-12-2013
209 Siemens Medical Solutions USA, Inc II Dec-03-2012
210 Siemens Medical Solutions USA, Inc II Oct-11-2012
211 Siemens Medical Solutions USA, Inc II Aug-27-2012
212 Siemens Medical Solutions USA, Inc II Aug-24-2012
213 Siemens Medical Solutions USA, Inc II Jul-26-2012
214 Siemens Medical Solutions USA, Inc II Feb-29-2012
215 Siemens Medical Solutions USA, Inc II Feb-20-2012
216 Siemens Medical Solutions USA, Inc II Jan-20-2012
217 Siemens Medical Solutions USA, Inc II Jan-11-2012
218 Siemens Medical Solutions USA, Inc II Jan-11-2012
219 Siemens Medical Solutions USA, Inc II Jan-11-2012
220 Siemens Medical Solutions USA, Inc II Jun-24-2010
221 Siemens Medical Solutions USA, Inc II Apr-20-2010
222 Siemens Medical Solutions USA, Inc II Nov-16-2009
223 Siemens Medical Solutions USA, Inc II Nov-10-2009
224 Siemens Medical Solutions USA, Inc II Jul-07-2009
225 Siemens Medical Solutions USA, Inc II Apr-28-2009
226 Siemens Medical Solutions USA, Inc II Apr-28-2009
227 Siemens Medical Solutions USA, Inc II Jan-08-2009
228 Siemens Medical Solutions USA, Inc II Dec-03-2008
229 Siemens Medical Solutions USA, Inc II Oct-15-2008
230 Siemens Medical Solutions USA, Inc II Aug-24-2008
231 Siemens Medical Solutions USA, Inc II Apr-29-2008
232 Siemens Medical Solutions USA, Inc II Feb-23-2008
233 Siemens Medical Solutions USA, Inc. II May-20-2008
234 Siemens Medical Solutions, USA, Inc II Aug-17-2012
235 Siemens Medical Solutions, USA, Inc II Jul-08-2011
236 Siemens Medical Solutions, USA, Inc II May-25-2011
237 Siemens Medical Solutions, USA, Inc II Jan-02-2009
238 Siemens Medical Solutions, USA, Inc II Sep-29-2008
239 Siemens Medical Solutions, USA, Inc II Mar-28-2007
240 Stentor Inc A Phillips Medical Systems Co. II Mar-13-2007
241 Straumann Manufacturing Inc. II Sep-13-2011
242 Straumann Manufacturing Inc. II Mar-07-2011
243 TeraRecon, Inc. II Feb-09-2015
244 Velocity Medical Solutions, LLC II Mar-25-2014
245 Vital Images, Inc. II Nov-06-2013
246 Vital Images, Inc. II Apr-26-2013
247 Vital Images, Inc. II Apr-18-2013
248 Vital Images, Inc. II Mar-27-2013
249 Vital Images, Inc. II Nov-01-2012
250 Vital Images, Inc. II Jan-11-2012
251 Vital Images, Inc. II Feb-02-2011
252 Vital Images, Inc. II Dec-21-2010
253 Vital Images, Inc. II May-13-2010
254 Vital Images, Inc. II Jan-31-2008
255 Xoran Technologies, Inc. II Jul-09-2009
256 iCAD, Inc. II Mar-04-2015

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