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

Device Problems
Programming issue 231
Computer software issue 74
Data Issue 67
Device operates differently than expected 54
Patient Data Issue 34
Device Issue 26
Loss of Data 23
No Known Device Problem 14
Computer operating system issue 11
Incorrect measurement 10
Device inoperable 10
Smoking 7
No display or display failure 7
Image display error 6
Overheating of device or device component 6
Application program issue 5
Device displays error message 4
Failure to power-up 4
Image orientation incorrect 4
Poor quality image 3
Incorrect display 3
Failure to back-up 3
Incorrect or inadequate result 3
Use of Device Issue 3
No code available 3
Malposition of device 2
Patient-device incompatibility 2
Structural problem 2
Data back-up problem 2
Fitting problem 2
Size incorrect for patient 2
Incorrect software programming calculations 2
Difficult to position 2
Nonstandard device or device component 2
Image reversal 2
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
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
Malfunction 1
Incorrect or inadequate test results 1
Operating system becomes non-functional 1
Problem with software installation 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Incorrect error code 1
Installation-related problem 1
Device handling issue 1
Missing test results 1
Total Device Problems 664

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 38
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 Aug-17-2016
68 GE Healthcare It II Jan-14-2014
69 GE Healthcare It II Oct-30-2013
70 GE Healthcare It II Oct-21-2013
71 GE Healthcare, LLC II Apr-25-2014
72 GE Healthcare, LLC II Nov-13-2013
73 GE Healthcare, LLC II Sep-19-2013
74 GE Healthcare, LLC II Sep-18-2013
75 GE Healthcare, LLC II Aug-27-2013
76 GE Healthcare, LLC II Apr-23-2013
77 GE Healthcare, LLC II Apr-17-2013
78 GE Healthcare, LLC II Dec-19-2012
79 GE Healthcare, LLC II Oct-24-2012
80 GE Healthcare, LLC II Oct-19-2012
81 GE Healthcare, LLC II Aug-13-2012
82 GE Healthcare, LLC II Jul-09-2012
83 GE Healthcare, LLC II Jan-11-2012
84 GE Healthcare, LLC II Sep-27-2011
85 GE Healthcare, LLC II Aug-12-2011
86 GE Healthcare, LLC II Feb-15-2011
87 GE Healthcare, LLC II Dec-03-2010
88 GE Healthcare, LLC II Nov-26-2010
89 GE OEC Medical Systems, Inc II Dec-17-2013
90 GE OEC Medical Systems, Inc I Aug-28-2012
91 GE OEC Medical Systems, Inc II Aug-22-2012
92 GE OEC Medical Systems, Inc I Aug-08-2012
93 GE OEC Medical Systems, Inc I Jul-12-2012
94 GE OEC Medical Systems, Inc II Apr-11-2011
95 GE OEC Medical Systems, Inc II Jan-23-2008
96 GE OEC Medical Systems, Inc II Nov-10-2007
97 GE OEC Medical Systems, Inc III Aug-07-2007
98 GE OEC Medical Systems,Inc II Mar-30-2007
99 Ge Healthcare It II Jul-28-2016
100 Ge Healthcare It II Jan-15-2014
101 Ge Healthcare It II Jan-14-2014
102 Ge Healthcare It II Oct-30-2013
103 Ge Healthcare It II Apr-16-2010
104 Ge Healthcare It II Apr-15-2010
105 Ge Healthcare, Llc II Jun-02-2010
106 Hologic, Inc. II Apr-05-2012
107 IMTEC IMAGING L.L.C. II Sep-22-2009
108 Imaging Sciences International, LLC II Sep-26-2012
109 Intelerad Medical Systems II Aug-19-2014
110 Intelerad Medical Systems Inc. II Aug-27-2009
111 Intio Inc II Mar-20-2013
112 MIMvista Corp II Sep-03-2008
113 Mckesson Information Solutions LLC II Feb-12-2014
114 Mckesson Information Solutions LLC II Dec-20-2013
115 Mckesson Information Solutions LLC II Sep-30-2013
116 Mckesson Information Solutions LLC II Aug-18-2011
117 Mckesson Medical Imaging Group II Sep-22-2016
118 Mckesson Medical Imaging Group II Aug-22-2012
119 Mckesson Medical Immaging II Mar-17-2016
120 Mckesson Medical Immaging II Jul-28-2014
121 Mckesson Medical Immaging II Jun-06-2014
122 Mckesson Medical Immaging II May-13-2014
123 Mckesson Medical Immaging II May-28-2010
124 Medtronic Navigation, Inc. II Jul-13-2010
125 Merge Healthcare, Inc. II Sep-22-2016
126 Merge Healthcare, Inc. II Sep-21-2016
127 Merge Healthcare, Inc. II Sep-14-2016
128 Merge Healthcare, Inc. II Sep-02-2016
129 Merge Healthcare, Inc. II Sep-01-2016
130 Merge Healthcare, Inc. II Aug-29-2016
131 Merge Healthcare, Inc. II Aug-23-2016
132 Merge Healthcare, Inc. II Aug-16-2016
133 Merge Healthcare, Inc. II Aug-12-2016
134 Merge Healthcare, Inc. II Aug-10-2016
135 Merge Healthcare, Inc. II Aug-08-2016
136 Merge Healthcare, Inc. II Jul-29-2016
137 Merge Healthcare, Inc. II Jul-29-2016
138 Merge Healthcare, Inc. II Jul-11-2016
139 Merge Healthcare, Inc. II Jul-08-2016
140 Merge Healthcare, Inc. II Feb-10-2016
141 Merge Healthcare, Inc. II Dec-28-2015
142 Merge Healthcare, Inc. II Oct-15-2014
143 Novarad Corporation II Aug-25-2016
144 Novarad Corporation II Jul-11-2016
145 Novarad Corporation II May-06-2016
146 Philips Electronics North America Corporation II Aug-29-2016
147 Philips Healthcare Inc. II Oct-07-2011
148 Philips Healthcare Inc. II Sep-14-2011
149 Philips Healthcare Informatics, Inc. II Aug-16-2014
150 Philips Healthcare Informatics, Inc. II Nov-13-2013
151 Philips Healthcare Informatics, Inc. II Jan-30-2009
152 Philips Healthcare Informatics, Inc. II Oct-28-2008
153 Philips Healthcare Informatics, Inc. II Sep-18-2008
154 Philips Healthcare Informatics, Inc. II Aug-16-2008
155 Philips Healthcare Informatics, Inc. II May-08-2008
156 Philips Medical Systems II Nov-10-2011
157 Philips Medical Systems North America Co. Phillips II Feb-04-2011
158 Philips Medical Systems North America Co. Phillips II Nov-18-2010
159 Philips Medical Systems North America Co. Phillips II Sep-16-2008
160 Philips Medical Systems, Inc. II Apr-24-2014
161 Philips Ultrasound, Inc. II Jun-15-2015
162 Philips Ultrasound, Inc. II Dec-16-2014
163 Philips Ultrasound, Inc. II Jul-23-2014
164 Siemens Medical Solutions USA, Inc II Sep-21-2016
165 Siemens Medical Solutions USA, Inc II Sep-14-2016
166 Siemens Medical Solutions USA, Inc II Jul-20-2016
167 Siemens Medical Solutions USA, Inc II Jun-30-2016
168 Siemens Medical Solutions USA, Inc II Jun-29-2016
169 Siemens Medical Solutions USA, Inc II May-04-2016
170 Siemens Medical Solutions USA, Inc II Apr-07-2016
171 Siemens Medical Solutions USA, Inc II Mar-23-2016
172 Siemens Medical Solutions USA, Inc II Mar-17-2016
173 Siemens Medical Solutions USA, Inc II Feb-23-2016
174 Siemens Medical Solutions USA, Inc II Feb-19-2016
175 Siemens Medical Solutions USA, Inc II Jan-06-2016
176 Siemens Medical Solutions USA, Inc II Dec-24-2015
177 Siemens Medical Solutions USA, Inc II Nov-20-2015
178 Siemens Medical Solutions USA, Inc II Sep-02-2015
179 Siemens Medical Solutions USA, Inc II Jul-02-2015
180 Siemens Medical Solutions USA, Inc II Jun-03-2015
181 Siemens Medical Solutions USA, Inc II Mar-30-2015
182 Siemens Medical Solutions USA, Inc II Jan-28-2015
183 Siemens Medical Solutions USA, Inc II Dec-15-2014
184 Siemens Medical Solutions USA, Inc II Jul-23-2014
185 Siemens Medical Solutions USA, Inc II May-16-2014
186 Siemens Medical Solutions USA, Inc II May-13-2014
187 Siemens Medical Solutions USA, Inc II Mar-18-2014
188 Siemens Medical Solutions USA, Inc II Nov-13-2013
189 Siemens Medical Solutions USA, Inc II Aug-15-2013
190 Siemens Medical Solutions USA, Inc II Aug-01-2013
191 Siemens Medical Solutions USA, Inc II Apr-12-2013
192 Siemens Medical Solutions USA, Inc II Dec-03-2012
193 Siemens Medical Solutions USA, Inc II Oct-11-2012
194 Siemens Medical Solutions USA, Inc II Aug-27-2012
195 Siemens Medical Solutions USA, Inc II Aug-24-2012
196 Siemens Medical Solutions USA, Inc II Jul-26-2012
197 Siemens Medical Solutions USA, Inc II Feb-29-2012
198 Siemens Medical Solutions USA, Inc II Feb-20-2012
199 Siemens Medical Solutions USA, Inc II Jan-20-2012
200 Siemens Medical Solutions USA, Inc II Jan-11-2012
201 Siemens Medical Solutions USA, Inc II Jan-11-2012
202 Siemens Medical Solutions USA, Inc II Jan-11-2012
203 Siemens Medical Solutions USA, Inc II Jun-24-2010
204 Siemens Medical Solutions USA, Inc II Apr-20-2010
205 Siemens Medical Solutions USA, Inc II Nov-16-2009
206 Siemens Medical Solutions USA, Inc II Nov-10-2009
207 Siemens Medical Solutions USA, Inc II Jul-07-2009
208 Siemens Medical Solutions USA, Inc II Apr-28-2009
209 Siemens Medical Solutions USA, Inc II Apr-28-2009
210 Siemens Medical Solutions USA, Inc II Jan-08-2009
211 Siemens Medical Solutions USA, Inc II Dec-03-2008
212 Siemens Medical Solutions USA, Inc II Oct-15-2008
213 Siemens Medical Solutions USA, Inc II Aug-24-2008
214 Siemens Medical Solutions USA, Inc II Apr-29-2008
215 Siemens Medical Solutions USA, Inc II Feb-23-2008
216 Siemens Medical Solutions USA, Inc. II May-20-2008
217 Siemens Medical Solutions, USA, Inc II Aug-17-2012
218 Siemens Medical Solutions, USA, Inc II Jul-08-2011
219 Siemens Medical Solutions, USA, Inc II May-25-2011
220 Siemens Medical Solutions, USA, Inc II Jan-02-2009
221 Siemens Medical Solutions, USA, Inc II Sep-29-2008
222 Siemens Medical Solutions, USA, Inc II Mar-28-2007
223 Stentor Inc A Phillips Medical Systems Co. II Mar-13-2007
224 Straumann Manufacturing Inc. II Sep-13-2011
225 Straumann Manufacturing Inc. II Mar-07-2011
226 TeraRecon, Inc. II Feb-09-2015
227 Velocity Medical Solutions, LLC II Mar-25-2014
228 Vital Images, Inc. II Nov-06-2013
229 Vital Images, Inc. II Apr-26-2013
230 Vital Images, Inc. II Apr-18-2013
231 Vital Images, Inc. II Mar-27-2013
232 Vital Images, Inc. II Nov-01-2012
233 Vital Images, Inc. II Jan-11-2012
234 Vital Images, Inc. II Feb-02-2011
235 Vital Images, Inc. II Dec-21-2010
236 Vital Images, Inc. II May-13-2010
237 Vital Images, Inc. II Jan-31-2008
238 Xoran Technologies, Inc. II Jul-09-2009
239 iCAD, Inc. II Mar-04-2015

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