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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 72
Data Issue 62
Device operates differently than expected 53
Patient Data Issue 33
Device Issue 26
Loss of Data 20
No Known Device Problem 14
Computer operating system issue 11
Device inoperable 10
Incorrect measurement 9
No display or display failure 7
Image display error 6
Smoking 5
Application program issue 5
Device displays error message 4
Overheating of device or device component 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 647

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 26
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 Aug-22-2012
118 Mckesson Medical Immaging II Mar-17-2016
119 Mckesson Medical Immaging II Jul-28-2014
120 Mckesson Medical Immaging II Jun-06-2014
121 Mckesson Medical Immaging II May-13-2014
122 Mckesson Medical Immaging II May-28-2010
123 Medtronic Navigation, Inc. II Jul-13-2010
124 Merge Healthcare, Inc. II Aug-16-2016
125 Merge Healthcare, Inc. II Aug-12-2016
126 Merge Healthcare, Inc. II Aug-10-2016
127 Merge Healthcare, Inc. II Aug-08-2016
128 Merge Healthcare, Inc. II Jul-29-2016
129 Merge Healthcare, Inc. II Jul-29-2016
130 Merge Healthcare, Inc. II Jul-11-2016
131 Merge Healthcare, Inc. II Jul-08-2016
132 Merge Healthcare, Inc. II Feb-10-2016
133 Merge Healthcare, Inc. II Dec-28-2015
134 Merge Healthcare, Inc. II Oct-15-2014
135 Novarad Corporation II Jul-11-2016
136 Novarad Corporation II May-06-2016
137 Philips Healthcare Inc. II Oct-07-2011
138 Philips Healthcare Inc. II Sep-14-2011
139 Philips Healthcare Informatics, Inc. II Aug-16-2014
140 Philips Healthcare Informatics, Inc. II Nov-13-2013
141 Philips Healthcare Informatics, Inc. II Jan-30-2009
142 Philips Healthcare Informatics, Inc. II Oct-28-2008
143 Philips Healthcare Informatics, Inc. II Sep-18-2008
144 Philips Healthcare Informatics, Inc. II Aug-16-2008
145 Philips Healthcare Informatics, Inc. II May-08-2008
146 Philips Medical Systems II Nov-10-2011
147 Philips Medical Systems North America Co. Phillips II Feb-04-2011
148 Philips Medical Systems North America Co. Phillips II Nov-18-2010
149 Philips Medical Systems North America Co. Phillips II Sep-16-2008
150 Philips Medical Systems, Inc. II Apr-24-2014
151 Philips Ultrasound, Inc. II Jun-15-2015
152 Philips Ultrasound, Inc. II Dec-16-2014
153 Philips Ultrasound, Inc. II Jul-23-2014
154 Siemens Medical Solutions USA, Inc II Jul-20-2016
155 Siemens Medical Solutions USA, Inc II Jun-30-2016
156 Siemens Medical Solutions USA, Inc II Jun-29-2016
157 Siemens Medical Solutions USA, Inc II May-04-2016
158 Siemens Medical Solutions USA, Inc II Apr-07-2016
159 Siemens Medical Solutions USA, Inc II Mar-23-2016
160 Siemens Medical Solutions USA, Inc II Mar-17-2016
161 Siemens Medical Solutions USA, Inc II Feb-23-2016
162 Siemens Medical Solutions USA, Inc II Feb-19-2016
163 Siemens Medical Solutions USA, Inc II Jan-06-2016
164 Siemens Medical Solutions USA, Inc II Dec-24-2015
165 Siemens Medical Solutions USA, Inc II Nov-20-2015
166 Siemens Medical Solutions USA, Inc II Sep-02-2015
167 Siemens Medical Solutions USA, Inc II Jul-02-2015
168 Siemens Medical Solutions USA, Inc II Jun-03-2015
169 Siemens Medical Solutions USA, Inc II Mar-30-2015
170 Siemens Medical Solutions USA, Inc II Jan-28-2015
171 Siemens Medical Solutions USA, Inc II Dec-15-2014
172 Siemens Medical Solutions USA, Inc II Jul-23-2014
173 Siemens Medical Solutions USA, Inc II May-16-2014
174 Siemens Medical Solutions USA, Inc II May-13-2014
175 Siemens Medical Solutions USA, Inc II Mar-18-2014
176 Siemens Medical Solutions USA, Inc II Nov-13-2013
177 Siemens Medical Solutions USA, Inc II Aug-15-2013
178 Siemens Medical Solutions USA, Inc II Aug-01-2013
179 Siemens Medical Solutions USA, Inc II Apr-12-2013
180 Siemens Medical Solutions USA, Inc II Dec-03-2012
181 Siemens Medical Solutions USA, Inc II Oct-11-2012
182 Siemens Medical Solutions USA, Inc II Aug-27-2012
183 Siemens Medical Solutions USA, Inc II Aug-24-2012
184 Siemens Medical Solutions USA, Inc II Jul-26-2012
185 Siemens Medical Solutions USA, Inc II Feb-29-2012
186 Siemens Medical Solutions USA, Inc II Feb-20-2012
187 Siemens Medical Solutions USA, Inc II Jan-20-2012
188 Siemens Medical Solutions USA, Inc II Jan-11-2012
189 Siemens Medical Solutions USA, Inc II Jan-11-2012
190 Siemens Medical Solutions USA, Inc II Jan-11-2012
191 Siemens Medical Solutions USA, Inc II Jun-24-2010
192 Siemens Medical Solutions USA, Inc II Apr-20-2010
193 Siemens Medical Solutions USA, Inc II Nov-16-2009
194 Siemens Medical Solutions USA, Inc II Nov-10-2009
195 Siemens Medical Solutions USA, Inc II Jul-07-2009
196 Siemens Medical Solutions USA, Inc II Apr-28-2009
197 Siemens Medical Solutions USA, Inc II Apr-28-2009
198 Siemens Medical Solutions USA, Inc II Jan-08-2009
199 Siemens Medical Solutions USA, Inc II Dec-03-2008
200 Siemens Medical Solutions USA, Inc II Oct-15-2008
201 Siemens Medical Solutions USA, Inc II Aug-24-2008
202 Siemens Medical Solutions USA, Inc II Apr-29-2008
203 Siemens Medical Solutions USA, Inc II Feb-23-2008
204 Siemens Medical Solutions USA, Inc. II May-20-2008
205 Siemens Medical Solutions, USA, Inc II Aug-17-2012
206 Siemens Medical Solutions, USA, Inc II Jul-08-2011
207 Siemens Medical Solutions, USA, Inc II May-25-2011
208 Siemens Medical Solutions, USA, Inc II Jan-02-2009
209 Siemens Medical Solutions, USA, Inc II Sep-29-2008
210 Siemens Medical Solutions, USA, Inc II Mar-28-2007
211 Stentor Inc A Phillips Medical Systems Co. II Mar-13-2007
212 Straumann Manufacturing Inc. II Sep-13-2011
213 Straumann Manufacturing Inc. II Mar-07-2011
214 TeraRecon, Inc. II Feb-09-2015
215 Velocity Medical Solutions, LLC II Mar-25-2014
216 Vital Images, Inc. II Nov-06-2013
217 Vital Images, Inc. II Apr-26-2013
218 Vital Images, Inc. II Apr-18-2013
219 Vital Images, Inc. II Mar-27-2013
220 Vital Images, Inc. II Nov-01-2012
221 Vital Images, Inc. II Jan-11-2012
222 Vital Images, Inc. II Feb-02-2011
223 Vital Images, Inc. II Dec-21-2010
224 Vital Images, Inc. II May-13-2010
225 Vital Images, Inc. II Jan-31-2008
226 Xoran Technologies, Inc. II Jul-09-2009
227 iCAD, Inc. II Mar-04-2015

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