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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 4
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 17
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 47
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 8
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 63
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 10
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 21
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No display or display failure 4
Image display error 4
Image orientation incorrect 3
Image reversal 2
Failure to back-up 2
Device displays error message 2
Computer software issue 2
Device operates differently than expected 1
Blank screen 1
Burn of device or device component 1
Mislocation 1
Device emits odor 1
Failure to power-up 1
Failure to transmit record 1
Smoking 1
Other (for use when an appropriate device code cannot be identified) 1
Device Issue 1
Malfunction 1
Total Device Problems 30

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 3 0
Class II 7 27 21 12 27 27 9
Class III 1 2 1 2 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Apr-08-2013
2 AGFA Corp. II Apr-08-2013
3 AGFA Corp. II Aug-22-2012
4 AGFA Corp. II Aug-10-2012
5 AGFA Corp. II Jul-24-2012
6 AGFA Corp. II Nov-23-2011
7 AGFA Corp. II Nov-18-2011
8 AGFA Corp. II Nov-18-2011
9 AGFA Corp. II Jun-10-2011
10 AGFA Corp. II May-24-2011
11 AGFA Corp. II Mar-16-2011
12 AGFA Corp. II Feb-25-2011
13 AGFA Corp. II Feb-24-2011
14 AGFA Corp. III Dec-29-2010
15 AGFA Corp. III Jun-11-2010
16 AGFA Corp. III Nov-18-2009
17 AGFA Corp. II Sep-08-2009
18 AGFA Corp. II Sep-02-2009
19 AGFA Corp. II Feb-03-2009
20 AGFA Corp. II Sep-11-2008
21 AGFA Corp. II Sep-11-2008
22 AGFA Corp. III Sep-04-2008
23 AGFA Corp. II Jul-02-2008
24 AGFA Corp. II Jun-27-2008
25 AGFA Corp. II Jun-27-2008
26 AGFA Corp. II Mar-31-2008
27 Cerner Corp II Sep-25-2007
28 Digisonics, Inc II May-13-2011
29 Digisonics, Inc II May-10-2011
30 Digisonics, Inc II May-10-2011
31 Digisonics, Inc II Apr-29-2011
32 Emageon III May-28-2008
33 Eos Imaging II Jun-28-2011
34 GE Healthcare II Sep-20-2008
35 GE Healthcare II Nov-28-2007
36 GE Healthcare Integrated IT Solutions II Nov-24-2009
37 GE Healthcare Integrated IT Solutions II Jul-13-2009
38 GE Healthcare Integrated IT Solutions II Jul-01-2009
39 GE Healthcare Integrated IT Solutions II Feb-03-2009
40 GE Healthcare Integrated IT Solutions II Feb-03-2009
41 GE Healthcare Integrated IT Solutions II Jan-27-2009
42 GE Healthcare Integrated IT Solutions II Jan-23-2009
43 GE Healthcare Integrated IT Solutions II Dec-13-2008
44 GE Healthcare Integrated IT Solutions II Sep-16-2008
45 GE Healthcare Integrated IT Solutions II Sep-02-2008
46 GE Healthcare Integrated IT Solutions II Sep-02-2008
47 GE Healthcare Integrated IT Solutions II May-01-2008
48 GE Healthcare Integrated IT Solutions II Jan-25-2007
49 GE Healthcare, LLC II Apr-23-2013
50 GE Healthcare, LLC II Apr-17-2013
51 GE Healthcare, LLC II Dec-19-2012
52 GE Healthcare, LLC II Oct-24-2012
53 GE Healthcare, LLC II Oct-19-2012
54 GE Healthcare, LLC II Aug-13-2012
55 GE Healthcare, LLC II Jul-09-2012
56 GE Healthcare, LLC II Jan-11-2012
57 GE Healthcare, LLC II Sep-27-2011
58 GE Healthcare, LLC II Aug-12-2011
59 GE Healthcare, LLC II Feb-15-2011
60 GE Healthcare, LLC II Dec-03-2010
61 GE Healthcare, LLC II Nov-26-2010
62 GE OEC Medical Systems, Inc I Aug-28-2012
63 GE OEC Medical Systems, Inc II Aug-22-2012
64 GE OEC Medical Systems, Inc I Aug-08-2012
65 GE OEC Medical Systems, Inc I Jul-12-2012
66 GE OEC Medical Systems, Inc II Apr-11-2011
67 GE OEC Medical Systems, Inc II Jan-23-2008
68 GE OEC Medical Systems, Inc II Nov-10-2007
69 GE OEC Medical Systems, Inc III Aug-07-2007
70 GE OEC Medical Systems,Inc II Mar-30-2007
71 Ge Healthcare It II Apr-16-2010
72 Ge Healthcare It II Apr-15-2010
73 Ge Healthcare, Llc II Jun-02-2010
74 Hologic, Inc. II Apr-05-2012
75 IMTEC IMAGING L.L.C. II Sep-22-2009
76 Imaging Sciences International, LLC II Sep-26-2012
77 Intelerad Medical Systems Inc. II Aug-27-2009
78 Intio Inc II Mar-20-2013
79 MIMvista Corp II Sep-03-2008
80 Mckesson Information Solutions LLC II Aug-18-2011
81 Mckesson Medical Imaging Group II Aug-22-2012
82 Mckesson Medical Immaging II May-28-2010
83 Medtronic Navigation, Inc. II Jul-13-2010
84 Philips Healthcare Inc. II Oct-07-2011
85 Philips Healthcare Inc. II Sep-14-2011
86 Philips Healthcare Informatics, Inc. II Jan-30-2009
87 Philips Healthcare Informatics, Inc. II Oct-28-2008
88 Philips Healthcare Informatics, Inc. II Sep-18-2008
89 Philips Healthcare Informatics, Inc. II Aug-16-2008
90 Philips Healthcare Informatics, Inc. II May-08-2008
91 Philips Medical Systems II Nov-10-2011
92 Philips Medical Systems North America Co. Phillips II Feb-04-2011
93 Philips Medical Systems North America Co. Phillips II Nov-18-2010
94 Philips Medical Systems North America Co. Phillips II Sep-16-2008
95 Siemens Medical Solutions USA, Inc II Apr-12-2013
96 Siemens Medical Solutions USA, Inc II Dec-03-2012
97 Siemens Medical Solutions USA, Inc II Oct-11-2012
98 Siemens Medical Solutions USA, Inc II Aug-27-2012
99 Siemens Medical Solutions USA, Inc II Aug-24-2012
100 Siemens Medical Solutions USA, Inc II Jul-26-2012
101 Siemens Medical Solutions USA, Inc II Feb-29-2012
102 Siemens Medical Solutions USA, Inc II Feb-20-2012
103 Siemens Medical Solutions USA, Inc II Jan-20-2012
104 Siemens Medical Solutions USA, Inc II Jan-11-2012
105 Siemens Medical Solutions USA, Inc II Jan-11-2012
106 Siemens Medical Solutions USA, Inc II Jan-11-2012
107 Siemens Medical Solutions USA, Inc II Jun-24-2010
108 Siemens Medical Solutions USA, Inc II Apr-20-2010
109 Siemens Medical Solutions USA, Inc II Nov-16-2009
110 Siemens Medical Solutions USA, Inc II Nov-10-2009
111 Siemens Medical Solutions USA, Inc II Jul-07-2009
112 Siemens Medical Solutions USA, Inc II Apr-28-2009
113 Siemens Medical Solutions USA, Inc II Apr-28-2009
114 Siemens Medical Solutions USA, Inc II Jan-08-2009
115 Siemens Medical Solutions USA, Inc II Dec-03-2008
116 Siemens Medical Solutions USA, Inc II Oct-15-2008
117 Siemens Medical Solutions USA, Inc II Aug-24-2008
118 Siemens Medical Solutions USA, Inc II Apr-29-2008
119 Siemens Medical Solutions USA, Inc II Feb-23-2008
120 Siemens Medical Solutions USA, Inc. II May-20-2008
121 Siemens Medical Solutions, USA, Inc II Aug-17-2012
122 Siemens Medical Solutions, USA, Inc II Jul-08-2011
123 Siemens Medical Solutions, USA, Inc II May-25-2011
124 Siemens Medical Solutions, USA, Inc II Jan-02-2009
125 Siemens Medical Solutions, USA, Inc II Sep-29-2008
126 Siemens Medical Solutions, USA, Inc II Mar-28-2007
127 Stentor Inc A Phillips Medical Systems Co. II Mar-13-2007
128 Straumann Manufacturing Inc. II Sep-13-2011
129 Straumann Manufacturing Inc. II Mar-07-2011
130 Vital Images, Inc. II Apr-26-2013
131 Vital Images, Inc. II Apr-18-2013
132 Vital Images, Inc. II Mar-27-2013
133 Vital Images, Inc. II Nov-01-2012
134 Vital Images, Inc. II Jan-11-2012
135 Vital Images, Inc. II Feb-02-2011
136 Vital Images, Inc. II Dec-21-2010
137 Vital Images, Inc. II May-13-2010
138 Vital Images, Inc. II Jan-31-2008
139 Xoran Technologies, Inc. II Jul-09-2009

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