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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accelerator, linear, medical
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
ACCURAY INCORPORTAED
  SUBSTANTIALLY EQUIVALENT 1
AKTINA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEST NOMOS
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 5
C-RAD POSITIONING AB
  SUBSTANTIALLY EQUIVALENT 2
CABLON MEDICAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CARINA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CNMC CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 2
ELECKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 4
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 2
ELEKTA, INC
  SUBSTANTIALLY EQUIVALENT 1
ESSEBI MEDICAL SRL
  SUBSTANTIALLY EQUIVALENT 1
FOCAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANDAUER
  SUBSTANTIALLY EQUIVALENT 1
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 2
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 2
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC DBA CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAP
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC, INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO
  SUBSTANTIALLY EQUIVALENT 1
MICROPOS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
NASLUND MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2
ORFIT INDUSTRIES NV
  SUBSTANTIALLY EQUIVALENT 3
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PANACEA MEDICAL TECHNOLOGIES PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
POLL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH TECHNISCHE-WERKSRAETTEN
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
  SUBSTANTIALLY EQUIVALENT 3
QFIX
  SUBSTANTIALLY EQUIVALENT 3
QUALIFORMED SARL
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
RADIALOGICA LLC
  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 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIT SORDINA IORT TECHNOLOGIES SPA
  SUBSTANTIALLY EQUIVALENT 2
SUN NUCLEAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 4
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 4
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 11
VIEWRAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 4
ZAP SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 125 125
2018 85 85
2019 91 91
2020 74 74
2021 69 69
2022 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 227 227
Use of Device Problem 26 26
Adverse Event Without Identified Device or Use Problem 19 19
Device Operates Differently Than Expected 18 18
Detachment of Device or Device Component 17 17
Unintended Movement 17 17
Unintended System Motion 16 16
Component Falling 15 15
Fluid Leak 15 15
Break 14 14
Malposition of Device 10 10
Unintended Collision 9 9
No Apparent Adverse Event 9 9
Data Problem 8 8
Improper or Incorrect Procedure or Method 8 8
Mechanical Problem 8 8
Communication or Transmission Problem 8 8
Application Program Problem 8 8
Loss of Data 7 7
Application Program Problem: Dose Calculation Error 7 7
Loose or Intermittent Connection 6 6
Material Deformation 6 6
Compatibility Problem 5 5
Device Handling Problem 5 5
Insufficient Information 5 5
Use of Incorrect Control Settings 5 5
Labelling, Instructions for Use or Training Problem 4 4
Device Operational Issue 4 4
Computer Operating System Problem 4 4
Defective Component 4 4
Material Integrity Problem 4 4
Mechanics Altered 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Fell 3 3
Installation-Related Problem 3 3
Human-Device Interface Problem 3 3
Output Problem 3 3
Radiation Overexposure 3 3
Component Missing 3 3
Device Issue 3 3
Display or Visual Feedback Problem 3 3
Electrical /Electronic Property Problem 3 3
Thermal Decomposition of Device 3 3
Disconnection 2 2
Image Orientation Incorrect 2 2
Product Quality Problem 2 2
Unstable 2 2
Inadequate or Insufficient Training 2 2
Retraction Problem 2 2
Self-Activation or Keying 2 2
Application Network Problem 2 2
Computer System Security Problem 2 2
Connection Problem 2 2
Activation, Positioning or SeparationProblem 2 2
Positioning Problem 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 2 2
Component Misassembled 2 2
Material Too Soft/Flexible 2 2
Calibration Problem 2 2
Human Factors Issue 2 2
Inadequate User Interface 2 2
Program or Algorithm Execution Problem 2 2
Incomplete or Inadequate Connection 1 1
Missing Information 1 1
Misassembly During Maintenance/Repair 1 1
Inadequate Lubrication 1 1
Unexpected/Unintended Radiation Output 1 1
Excessive Heating 1 1
Operating System Version or Upgrade Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Device Markings/Labelling Problem 1 1
Improper Chemical Reaction 1 1
Improper Device Output 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Split, Cut or Torn 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Radiation Underexposure 1 1
Reset Problem 1 1
Temperature Problem 1 1
Application Security Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Microbial Contamination of Device 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Sticking 1 1
Device Inoperable 1 1
Misconnection 1 1
Device Emits Odor 1 1
Visual Prompts will not Clear 1 1
Failure to Advance 1 1
Split 1 1
Defective Device 1 1
Device Tipped Over 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 144 144
No Clinical Signs, Symptoms or Conditions 120 120
No Information 91 91
Insufficient Information 82 82
No Consequences Or Impact To Patient 78 78
No Patient Involvement 53 53
Radiation Overdose 17 17
Unintended Radiation Exposure 6 6
No Code Available 4 4
Injury 4 4
Bone Fracture(s) 4 4
Radiation Burn 4 4
Pain 4 4
Radiation Underdose 3 3
Inflammation 3 3
Laceration(s) 3 3
Patient Problem/Medical Problem 3 3
Headache 2 2
Radiation Exposure, Unintended 2 2
Abrasion 2 2
Burn(s) 2 2
Death 1 1
Diarrhea 1 1
Fall 1 1
Fatigue 1 1
Fever 1 1
Fistula 1 1
Bruise/Contusion 1 1
Head Injury 1 1
Memory Loss/Impairment 1 1
Necrosis 1 1
Neuropathy 1 1
Overdose 1 1
Tingling 1 1
Chills 1 1
Dizziness 1 1
Brain Injury 1 1
Radiodermatitis 1 1
Urinary Frequency 1 1
Complaint, Ill-Defined 1 1
Skin Discoloration 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Swelling 1 1
Blurred Vision 1 1
Weakness 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Not Applicable 1 1
Full thickness (Third Degree) Burn 1 1
High Blood Pressure/ Hypertension 1 1
Incontinence 1 1
Fracture, Arm 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Reaction 1 1
Irritability 1 1
Neck Pain 1 1
Sweating 1 1
Suture Abrasion 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Incorporated II Mar-17-2021
2 Accuray Incorporated II Jan-07-2021
3 Accuray Incorporated II Jun-01-2019
4 Accuray Incorporated II Nov-08-2018
5 Accuray Incorporated II Sep-20-2018
6 Accuray Incorporated II Dec-26-2017
7 Brainlab AG II Mar-08-2022
8 Brainlab AG II Jun-10-2021
9 Brainlab AG II Mar-08-2021
10 Brainlab AG II Mar-14-2018
11 Brainlab AG II Nov-28-2017
12 C-RAD POSITIONING AB II Jul-14-2021
13 ELEKTA SOLUTIONS AB II Oct-14-2021
14 Elekta Limited II Jun-08-2020
15 Elekta Limited II May-08-2019
16 Elekta Limited II Apr-08-2019
17 Elekta Limited II Jan-09-2019
18 Elekta Limited II Feb-26-2018
19 Elekta, Inc. II Oct-14-2021
20 Elekta, Inc. II Sep-29-2021
21 Elekta, Inc. II Jun-02-2021
22 Elekta, Inc. II Jun-30-2020
23 Elekta, Inc. II Jun-05-2020
24 Elekta, Inc. II Aug-09-2019
25 Elekta, Inc. II Jul-16-2019
26 Elekta, Inc. II Feb-08-2019
27 Elekta, Inc. II Dec-27-2018
28 Elekta, Inc. II Aug-23-2018
29 Elekta, Inc. II Aug-17-2018
30 Elekta, Inc. II Aug-10-2017
31 Elekta, Inc. II Jun-27-2017
32 Hitachi Ltd., Medical System Operations Group II May-01-2018
33 Iba Dosimetry II Jun-02-2017
34 Klarity Medical Products LLC II Aug-24-2020
35 Med Tec Inc II Jun-02-2020
36 Med Tec Inc II Jun-18-2019
37 Medical Intelligence Medizintechnik Gmbh II Jul-25-2019
38 Mobius Medical Systems, LP II May-16-2017
39 PTW NORTH AMERICA CORPORATION II Jan-11-2022
40 Reflexion Medical, Inc. II Jan-10-2022
41 Siemens Medical Solutions USA, Inc II Dec-29-2021
42 Siemens Medical Solutions USA, Inc II Apr-07-2020
43 Siemens Medical Solutions USA, Inc II Feb-21-2020
44 Siemens Medical Solutions USA, Inc II Aug-06-2019
45 Siemens Medical Solutions USA, Inc II Apr-19-2019
46 Siemens Medical Solutions USA, Inc II Apr-17-2018
47 Siemens Medical Solutions USA, Inc II Mar-20-2017
48 Siemens Medical Solutions USA, Inc II Mar-09-2017
49 Siemens Medical Solutions USA, Inc II Feb-16-2017
50 Varian Medical Systems II Oct-01-2018
51 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
52 Varian Medical Systems, Inc. II May-05-2020
53 Varian Medical Systems, Inc. II Jan-10-2017
54 Viewray, Inc. II Nov-20-2020
55 Viewray, Inc. II Apr-27-2020
56 Viewray, Inc. II Dec-12-2019
57 Viewray, Inc. II May-02-2019
58 Vision RT Ltd II Oct-03-2018
59 Zap Surgical Systems II Sep-14-2022
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