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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device accelerator, linear, medical
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 13
ACCURAY INCORPORTAED
  SUBSTANTIALLY EQUIVALENT 1
ACCURAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCUTHERA INC.
  SUBSTANTIALLY EQUIVALENT 1
AKTINA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
AKTINA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
AKTINA MEDICAL PHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
AURORA TECHNOLOGY DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEST MEDICAL CANADA LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEST NOMOS
  SUBSTANTIALLY EQUIVALENT 1
BFFL CO. INC
  SUBSTANTIALLY EQUIVALENT 1
BIONIX DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
C-RAD POSITIONING AB
  SUBSTANTIALLY EQUIVALENT 5
CABLON MEDICAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
CALYPSO MEDICAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARINA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CDR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CNMC CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
CNMC COMPANY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CORTEX MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 2
COSMAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIREX SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT SA
  SUBSTANTIALLY EQUIVALENT 1
DYN'R
  SUBSTANTIALLY EQUIVALENT 1
DYN'R SAS
  SUBSTANTIALLY EQUIVALENT 1
ELECKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 7
ELEKTA LTD.
  SUBSTANTIALLY EQUIVALENT 7
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
ELEKTA, INC
  SUBSTANTIALLY EQUIVALENT 1
ESSEBI MEDICAL SRL
  SUBSTANTIALLY EQUIVALENT 1
FOCAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC
  SUBSTANTIALLY EQUIVALENT 1
HUMEDIQ GMBH
  SUBSTANTIALLY EQUIVALENT 1
IBA DOSIMETRY GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPAC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA RADIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KALLISIO, INC
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KLARITY MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LANDAUER
  SUBSTANTIALLY EQUIVALENT 1
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 3
LARSON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
LINATECH, LLC
  SUBSTANTIALLY EQUIVALENT 2
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 4
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANTEIA TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MATH RESOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MATH RESOLUTIONS, LLC.
  SUBSTANTIALLY EQUIVALENT 2
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 3
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDTEC INC DBA CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAP
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC, INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO
  SUBSTANTIALLY EQUIVALENT 1
MICROPOS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
MITSUBISHI HEAVY INDUSTRIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MOBIUS MEDICAL SYSTEMS, LP
  SUBSTANTIALLY EQUIVALENT 3
NASLUND MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 4
NAVOTEK MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
NEW RADIANT TECHNOLOGY S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NOMICS
  SUBSTANTIALLY EQUIVALENT 1
ONCOLOG MEDICAL QA AB
  SUBSTANTIALLY EQUIVALENT 2
ONCOLOGY DATA SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORBITAL THERAPY, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORFIT INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
ORFIT INDUSTRIES NV
  SUBSTANTIALLY EQUIVALENT 8
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
P-CURE LTD
  SUBSTANTIALLY EQUIVALENT 1
PANACEA MEDICAL TECHNOLOGIES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
PANACEA MEDICAL TECHNOLOGIES PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
PAPRICALAB
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
  SUBSTANTIALLY EQUIVALENT 1
POLL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PROTON SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 1
PROWESS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PTW-FREIBURG PHYSIKALISCH TECHNISCHE-WERKSRAETTEN
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
  SUBSTANTIALLY EQUIVALENT 3
QFIX
  SUBSTANTIALLY EQUIVALENT 6
QUALIFORMED SARL
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
RADIALOGICA LLC
  SUBSTANTIALLY EQUIVALENT 1
RADIATION PRODUCTS DESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIATION PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
RADIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RADTEC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTSAFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 10
SIT SORDINA IORT TECHNOLOGIES SPA
  SUBSTANTIALLY EQUIVALENT 2
SORDINA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
STELLAR MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
SUN NUCLEAR CORP.
  SUBSTANTIALLY EQUIVALENT 2
SUN NUCLEAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 7
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 33
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
VIEWRAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 6
WISDOM TECHNOLOGIES., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZDI, SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 124 124
2015 100 100
2016 97 97
2017 125 125
2018 85 85
2019 91 91
2020 74 74
2021 68 68
2022 67 67
2023 128 128
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 445 445
Device Operates Differently Than Expected 57 57
Adverse Event Without Identified Device or Use Problem 45 45
Use of Device Problem 39 39
Unintended System Motion 31 31
Unintended Movement 28 28
Insufficient Information 24 24
Improper or Incorrect Procedure or Method 24 24
Detachment of Device or Device Component 23 23
Break 17 17
Component Falling 17 17
Unintended Collision 16 16
Fluid/Blood Leak 15 15
Device Displays Incorrect Message 14 14
Data Problem 13 13
Malposition of Device 12 12
Communication or Transmission Problem 12 12
Positioning Problem 12 12
Mechanical Problem 12 12
No Apparent Adverse Event 11 11
Application Program Problem 11 11
Display or Visual Feedback Problem 10 10
Device Handling Problem 10 10
Use of Incorrect Control/Treatment Settings 9 9
Loss of Data 9 9
Computer Operating System Problem 8 8
Application Program Problem: Dose Calculation Error 8 8
Loose or Intermittent Connection 8 8
Labelling, Instructions for Use or Training Problem 7 7
Electrical /Electronic Property Problem 7 7
Unstable 7 7
Off-Label Use 7 7
Protective Measures Problem 7 7
Radiation Overexposure 7 7
Compatibility Problem 7 7
Patient Data Problem 7 7
Material Deformation 6 6
Programming Issue 6 6
Appropriate Term/Code Not Available 5 5
Material Integrity Problem 5 5
Human-Device Interface Problem 5 5
Self-Activation or Keying 5 5
Therapy Delivered to Incorrect Body Area 4 4
Nonstandard Device 4 4
Device Slipped 4 4
Detachment Of Device Component 4 4
Installation-Related Problem 4 4
Improper Device Output 4 4
Mechanics Altered 4 4
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 4 4
Defective Component 4 4
Device Operational Issue 4 4
Device Fell 4 4
Noise, Audible 3 3
Intermittent Communication Failure 3 3
Connection Problem 3 3
Incorrect Or Inadequate Test Results 3 3
Failure to Align 3 3
Application Network Problem 3 3
Temperature Problem 3 3
Operating System Version or Upgrade Problem 3 3
Inadequate User Interface 3 3
Calibration Problem 3 3
Human Factors Issue 3 3
Thermal Decomposition of Device 3 3
Inadequate Instructions for Healthcare Professional 3 3
Fire 3 3
Disconnection 3 3
No Display/Image 3 3
Retraction Problem 3 3
Component Missing 3 3
Inaccurate Delivery 3 3
Device Issue 3 3
Device Emits Odor 3 3
Failure to Recalibrate 2 2
Failure to Transmit Record 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Sense 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Smoking 2 2
Product Quality Problem 2 2
Unexpected Therapeutic Results 2 2
Inadequate or Insufficient Training 2 2
Device Inoperable 2 2
Fracture 2 2
Image Display Error/Artifact 2 2
Image Orientation Incorrect 2 2
Incorrect Measurement 2 2
Melted 2 2
Misassembled 2 2
Calibration Error 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Issue With Displayed Error Message 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Misassembly by Users 2 2
Mechanical Jam 2 2
Low impedance 2 2
Computer System Security Problem 2 2
Data Back-Up Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 281 281
No Clinical Signs, Symptoms or Conditions 208 208
Insufficient Information 192 192
No Consequences Or Impact To Patient 133 133
No Information 122 122
No Patient Involvement 103 103
Radiation Overdose 20 20
Unintended Radiation Exposure 13 13
Radiation Exposure, Unintended 12 12
Pain 12 12
Bone Fracture(s) 11 11
Injury 10 10
No Code Available 10 10
Patient Problem/Medical Problem 7 7
Unspecified Infection 7 7
Laceration(s) 6 6
Radiation Burn 6 6
Headache 5 5
Inflammation 5 5
Radiation Underdose 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Electric Shock 4 4
Overdose 4 4
Complaint, Ill-Defined 4 4
Dyspnea 4 4
Burn(s) 3 3
Bacterial Infection 3 3
Fever 3 3
Weakness 3 3
Burning Sensation 3 3
Confusion/ Disorientation 3 3
Test Result 3 3
Cancer 3 3
Not Applicable 3 3
Limb Fracture 2 2
Suture Abrasion 2 2
Neck Pain 2 2
Sweating 2 2
Neuropathy 2 2
Chills 2 2
Skin Discoloration 2 2
Dizziness 2 2
Reaction 2 2
Loss of consciousness 2 2
Necrosis 2 2
Infiltration into Tissue 2 2
Head Injury 2 2
Incontinence 2 2
Abrasion 2 2
Edema 2 2
Fall 2 2
Fatigue 2 2
Death 2 2
Dysphagia/ Odynophagia 2 2
Pulmonary Embolism 1 1
Dehydration 1 1
Diarrhea 1 1
Feeding Problem 1 1
Electrocution 1 1
Anemia 1 1
Bruise/Contusion 1 1
Chest Pain 1 1
Crushing Injury 1 1
Nerve Damage 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Fistula 1 1
Gastritis 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Tract Infection 1 1
Irritability 1 1
Fracture, Arm 1 1
Depression 1 1
Dyskinesia 1 1
Non-union Bone Fracture 1 1
Disability 1 1
Perforation of Esophagus 1 1
Dysphasia 1 1
Brain Injury 1 1
Radiodermatitis 1 1
Urinary Frequency 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Blurred Vision 1 1
Vomiting 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Concussion 1 1
Tingling 1 1
Hot Flashes/Flushes 1 1
Choking 1 1
Increased Respiratory Rate 1 1
Underdose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Inc II Jan-18-2011
2 Accuray Inc II Dec-16-2010
3 Accuray Inc II Sep-14-2009
4 Accuray Inc II Jan-17-2009
5 Accuray Incorporated II Aug-31-2023
6 Accuray Incorporated II Mar-17-2021
7 Accuray Incorporated II Jan-07-2021
8 Accuray Incorporated II Jun-01-2019
9 Accuray Incorporated II Nov-08-2018
10 Accuray Incorporated II Sep-20-2018
11 Accuray Incorporated II Dec-26-2017
12 Accuray Incorporated II Dec-21-2016
13 Accuray Incorporated II Dec-12-2016
14 Accuray Incorporated II Feb-09-2016
15 Accuray Incorporated II Nov-14-2014
16 Accuray Incorporated II Jan-27-2014
17 Accuray Incorporated II Apr-16-2013
18 Accuray Incorporated II Feb-23-2012
19 Accuray Incorporated II Jan-11-2012
20 Accuray Incorporated II Oct-11-2011
21 Brainlab AG II Mar-16-2023
22 Brainlab AG II Mar-08-2022
23 Brainlab AG II Jun-10-2021
24 Brainlab AG II Mar-08-2021
25 Brainlab AG II Mar-14-2018
26 Brainlab AG II Nov-28-2017
27 Brainlab AG II Jun-08-2016
28 Brainlab AG II Aug-21-2015
29 Brainlab AG II Mar-25-2015
30 Brainlab AG II Aug-04-2014
31 Brainlab AG II Jun-03-2014
32 Brainlab AG II Apr-25-2014
33 Brainlab AG II Aug-26-2013
34 Brainlab AG II Jul-02-2009
35 C-RAD POSITIONING AB II Jul-14-2021
36 Civco Medical Instruments Inc II Jan-21-2014
37 ELEKTA SOLUTIONS AB II Oct-14-2021
38 Elekta Limited II Jun-08-2020
39 Elekta Limited II May-08-2019
40 Elekta Limited II Apr-08-2019
41 Elekta Limited II Jan-09-2019
42 Elekta Limited II Feb-26-2018
43 Elekta, Inc. II Dec-01-2023
44 Elekta, Inc. II Jun-02-2023
45 Elekta, Inc. II May-30-2023
46 Elekta, Inc. II Oct-14-2021
47 Elekta, Inc. II Sep-29-2021
48 Elekta, Inc. II Jun-02-2021
49 Elekta, Inc. II Jun-30-2020
50 Elekta, Inc. II Jun-05-2020
51 Elekta, Inc. II Aug-09-2019
52 Elekta, Inc. II Jul-16-2019
53 Elekta, Inc. II Feb-08-2019
54 Elekta, Inc. II Dec-27-2018
55 Elekta, Inc. II Aug-23-2018
56 Elekta, Inc. II Aug-17-2018
57 Elekta, Inc. II Aug-10-2017
58 Elekta, Inc. II Jun-27-2017
59 Elekta, Inc. II Dec-09-2016
60 Elekta, Inc. II Sep-02-2016
61 Elekta, Inc. II Aug-30-2016
62 Elekta, Inc. II Jul-27-2016
63 Elekta, Inc. II Jun-27-2016
64 Elekta, Inc. II May-23-2016
65 Elekta, Inc. II Dec-29-2015
66 Elekta, Inc. II Dec-17-2015
67 Elekta, Inc. II Jul-14-2015
68 Elekta, Inc. II Jun-26-2015
69 Elekta, Inc. II Feb-10-2015
70 Elekta, Inc. II Nov-15-2014
71 Elekta, Inc. II Jun-25-2014
72 Elekta, Inc. II Jun-17-2014
73 Elekta, Inc. II Jun-16-2014
74 Elekta, Inc. II Jun-16-2014
75 Elekta, Inc. II Apr-02-2014
76 Elekta, Inc. II Mar-14-2014
77 Elekta, Inc. II Mar-07-2014
78 Elekta, Inc. II Mar-06-2014
79 Elekta, Inc. II Mar-06-2014
80 Elekta, Inc. II Mar-06-2014
81 Elekta, Inc. II Feb-20-2014
82 Elekta, Inc. II Feb-20-2014
83 Elekta, Inc. II May-25-2013
84 Elekta, Inc. II Mar-10-2013
85 Elekta, Inc. II Oct-30-2012
86 Elekta, Inc. II Sep-19-2012
87 Elekta, Inc. II Sep-10-2012
88 Elekta, Inc. II May-23-2012
89 Elekta, Inc. II Feb-21-2012
90 Elekta, Inc. II Dec-01-2011
91 Elekta, Inc. II Dec-01-2011
92 Elekta, Inc. II Nov-29-2011
93 Elekta, Inc. II Mar-22-2011
94 Elekta, Inc. II Mar-04-2011
95 Elekta, Inc. II Feb-15-2011
96 Elekta, Inc. II Dec-03-2010
97 Elekta, Inc. II Apr-27-2010
98 Elekta, Inc. II Apr-26-2010
99 Elekta, Inc. II Apr-22-2010
100 Elekta, Inc. II Apr-16-2010
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