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

Device Problems
Programming issue 231
Data Issue 78
Computer software issue 78
Device operates differently than expected 54
Patient Data Issue 35
Loss of Data 26
Device Issue 26
No Known Device Problem 15
Device inoperable 13
Computer operating system issue 11
Incorrect measurement 10
Smoking 9
Overheating of device or device component 8
No display or display failure 7
Image display error 6
Application program issue 6
Image orientation incorrect 5
Failure to power-up 4
Patient-device incompatibility 4
Device displays error message 4
Structural problem 3
No code available 3
Incorrect or inadequate result 3
Use of Device Issue 3
Poor quality image 3
Incorrect display 3
Failure to back-up 3
Nonstandard device or device component 2
Image reversal 2
Fitting problem 2
Size incorrect for patient 2
Incorrect software programming calculations 2
Difficult to position 2
Positioning Issue 2
Missing test results 2
Data back-up problem 2
Malposition of device 2
Malfunction 1
Incorrect or inadequate test results 1
Operating system becomes non-functional 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Improper device output 1
Incorrect error code 1
Installation-related problem 1
Device handling issue 1
Problem with software installation 1
Migration of device or device component 1
Mislocation 1
Failure to transmit record 1
User used incorrect product for intended use 1
Slippage of device or device component 1
Device stops intermittently 1
Other (for use when an appropriate device code cannot be identified) 1
Improper or incorrect procedure or method 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 700

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

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