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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 8
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 12
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 3
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
Pathfinder Therapeutics, Inc.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 29
RIVERAIN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 81
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 13
TROPHY
  SUBSTANTIALLY EQUIVALENT 3
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 28
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Programming issue 232
Computer software issue 123
Data Issue 92
Device operates differently than expected 56
Loss of Data 42
Patient Data Issue 38
Device Issue 34
No Known Device Problem 16
Computer operating system issue 11
Incorrect measurement 10
Smoking 9
Overheating of device or device component 8
Application program issue 8
Device inoperable 7
No display or display failure 7
Application interface becomes non-functional or program exits abnormally 6
Image display error 6
Image orientation incorrect 6
Device displays error message 5
Patient-device incompatibility 4
Incorrect display 4
Use of Device Issue 4
Failure to power-up 4
Incorrect or inadequate result 3
Failure to back-up 3
Poor quality image 3
Structural problem 3
No code available 3
Positioning Issue 2
Missing test results 2
Image reversal 2
Malposition of device 2
Data back-up problem 2
Nonstandard device or device component 2
Size incorrect for patient 2
Fitting problem 2
Incorrect software programming calculations 2
Difficult to position 2
Migration of device or device component 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
Improper or incorrect procedure or method 1
Slippage of device or device component 1
Device stops intermittently 1
Device emits odor 1
No device output 1
Image resolution poor 1
Erratic display 1
Failure to convert to back-up 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
Operating system becomes non-functional 1
Output issue 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Improper device output 1
Incorrect error code 1
Installation-related problem 1
Malfunction 1
Incorrect or inadequate test results 1
Problem with software installation 1
Not Applicable 1
Device handling issue 1
Total Device Problems 799

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

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