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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
Regulation Description Medical charged-particle radiation therapy system.
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 4
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
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
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 2
QFIX
  SUBSTANTIALLY EQUIVALENT 3
QUALIFORMED SARL
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 10
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

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 211 211
Use of Device Problem 24 24
Device Operates Differently Than Expected 18 18
Detachment of Device or Device Component 15 15
Component Falling 15 15
Fluid Leak 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Unintended Movement 15 15
Unintended System Motion 14 14
Break 13 13
Malposition of Device 10 10
Unintended Collision 9 9
No Apparent Adverse Event 9 9
Data Problem 8 8
Application Program Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Mechanical Problem 7 7
Application Program Problem: Dose Calculation Error 7 7
Loose or Intermittent Connection 6 6
Communication or Transmission Problem 5 5
Insufficient Information 5 5
Material Integrity Problem 4 4
Mechanics Altered 4 4
Computer Operating System Problem 4 4
Device Operational Issue 4 4
Compatibility Problem 4 4
Defective Component 4 4
Labelling, Instructions for Use or Training Problem 4 4
Use of Incorrect Control Settings 4 4
Thermal Decomposition of Device 3 3
Component Missing 3 3
Device Issue 3 3
Installation-Related Problem 3 3
Human-Device Interface Problem 3 3
Radiation Overexposure 3 3
Device Handling Problem 3 3
Noise, Audible 2 2
Component Misassembled 2 2
Material Too Soft/Flexible 2 2
Program or Algorithm Execution Problem 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 2 2
Inadequate User Interface 2 2
Human Factors Issue 2 2
Computer System Security Problem 2 2
Connection Problem 2 2
Loss of Data 2 2
Activation, Positioning or SeparationProblem 2 2
Retraction Problem 2 2
Self-Activation or Keying 2 2
Inadequate or Insufficient Training 2 2
Disconnection 2 2
Display or Visual Feedback Problem 2 2
Electrical /Electronic Property Problem 2 2
Image Orientation Incorrect 2 2
Product Quality Problem 2 2
Therapy Delivered to Incorrect Body Area 1 1
Failure to Recalibrate 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Misconnection 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Image Resolution Poor 1 1
Fire 1 1
Inadequate Instructions for Healthcare Professional 1 1
No Display/Image 1 1
Loss of or Failure to Bond 1 1
Fracture 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Calibration Error 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Crack 1 1
Decoupling 1 1
Deflation Problem 1 1
Degraded 1 1
Device Inoperable 1 1
Unstable 1 1
Sticking 1 1
Microbial Contamination of Device 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
Application Security Problem 1 1
Calibration Problem 1 1
Application Network Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Device Markings/Labelling Problem 1 1
Improper Device Output 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Operating System Version or Upgrade Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Programming Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 144 144
No Information 91 91
No Clinical Signs, Symptoms or Conditions 79 79
No Consequences Or Impact To Patient 78 78
Insufficient Information 55 55
No Patient Involvement 53 53
Radiation Overdose 17 17
Radiation Burn 4 4
Pain 4 4
Injury 4 4
No Code Available 4 4
Unintended Radiation Exposure 4 4
Patient Problem/Medical Problem 3 3
Radiation Underdose 3 3
Bone Fracture(s) 3 3
Laceration(s) 3 3
Abrasion 2 2
Burn(s) 2 2
Headache 2 2
Radiation Exposure, Unintended 2 2
Inflammation 2 2
Cancer 1 1
Not Applicable 1 1
Full thickness (Third Degree) Burn 1 1
High Blood Pressure/ Hypertension 1 1
Fracture, Arm 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Reaction 1 1
Irritability 1 1
Sweating 1 1
Suture Abrasion 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
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
Neuropathy 1 1
Overdose 1 1
Tingling 1 1
Chills 1 1
Dizziness 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

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