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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 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 7
C-RAD POSITIONING AB
  SUBSTANTIALLY EQUIVALENT 2
CARBON MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CARINA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT SA
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KALLISIO, INC
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 2
LINATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 3
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANTEIA TECHNOLOGIES CO., LTD.
  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 1
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PANACEA MEDICAL TECHNOLOGIES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
PANACEA MEDICAL TECHNOLOGIES PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
PAPRICALAB
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
  SUBSTANTIALLY EQUIVALENT 2
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN DR. PYCHLA
  SUBSTANTIALLY EQUIVALENT 1
QFIX
  SUBSTANTIALLY EQUIVALENT 2
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADTEC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 5
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 4
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 5
WISDOM TECHNOLOGIES., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 74 74
2021 68 68
2022 67 67
2023 128 128
2024 81 81
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 240 240
Use of Device Problem 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Unintended System Motion 16 16
Detachment of Device or Device Component 15 15
Fluid/Blood Leak 9 9
Unstable 9 9
Unintended Movement 9 9
Device Handling Problem 8 8
Communication or Transmission Problem 7 7
No Apparent Adverse Event 6 6
Break 6 6
Off-Label Use 6 6
Material Deformation 6 6
Improper or Incorrect Procedure or Method 5 5
Insufficient Information 5 5
Unintended Collision 4 4
Electrical /Electronic Property Problem 4 4
Data Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Fell 4 4
Mechanical Problem 4 4
Output Problem 4 4
Protective Measures Problem 3 3
Therapy Delivered to Incorrect Body Area 3 3
Intermittent Communication Failure 3 3
Use of Incorrect Control/Treatment Settings 3 3
Grounding Malfunction 2 2
Appropriate Term/Code Not Available 2 2
Inadequate or Insufficient Training 2 2
Low impedance 2 2
Compatibility Problem 2 2
Application Network Problem 2 2
Installation-Related Problem 2 2
Material Too Soft/Flexible 2 2
Product Quality Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Calibration Problem 2 2
Application Program Problem: Dose Calculation Error 2 2
Program or Algorithm Execution Problem 2 2
Loss of Data 2 2
Disconnection 2 2
Radiation Overexposure 2 2
Positioning Problem 2 2
Defective Component 2 2
Failure to Recalibrate 2 2
Patient-Device Incompatibility 2 2
Device Slipped 1 1
Loose or Intermittent Connection 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 263 263
Insufficient Information 233 233
No Information 24 24
No Consequences Or Impact To Patient 16 16
Unintended Radiation Exposure 13 13
No Known Impact Or Consequence To Patient 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
No Patient Involvement 9 9
Bone Fracture(s) 6 6
Abrasion 3 3
Incontinence 3 3
Cancer 2 2
Radiation Burn 2 2
Crushing Injury 2 2
Local Reaction 2 2
Limb Fracture 2 2
Laceration(s) 2 2
Decreased Appetite 1 1
Ambulation Difficulties 1 1
Respiratory Failure 1 1
Constipation 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Ulcer 1 1
Radiation Overdose 1 1
Swelling/ Edema 1 1
Radiodermatitis 1 1
Radiation Underdose 1 1
Fall 1 1
Dehydration 1 1
Viral Infection 1 1
Hernia 1 1
Pleural Effusion 1 1
Nerve Damage 1 1
Diarrhea 1 1
Foreign Body In Patient 1 1
Neck Pain 1 1
Burn(s) 1 1
Atrial Fibrillation 1 1
Inflammation 1 1
Head Injury 1 1
Necrosis 1 1
No Code Available 1 1
Brain Injury 1 1
Joint Dislocation 1 1
Melena 1 1
Patient Problem/Medical Problem 1 1
Dysphasia 1 1
Neuropathy 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Incorporated II Jan-27-2025
2 Accuray Incorporated II Aug-31-2023
3 Accuray Incorporated II Mar-17-2021
4 Accuray Incorporated II Jan-07-2021
5 Brainlab AG II Mar-16-2023
6 Brainlab AG II Mar-08-2022
7 Brainlab AG II Jun-10-2021
8 Brainlab AG II Mar-08-2021
9 C-RAD POSITIONING AB II Jul-14-2021
10 Carbon Medical Technologies, Inc. III Sep-17-2024
11 ELEKTA SOLUTIONS AB II Oct-14-2021
12 Elekta Limited II Jun-08-2020
13 Elekta, Inc. II Feb-12-2025
14 Elekta, Inc. II Dec-01-2023
15 Elekta, Inc. II Jun-02-2023
16 Elekta, Inc. II May-30-2023
17 Elekta, Inc. II Oct-14-2021
18 Elekta, Inc. II Sep-29-2021
19 Elekta, Inc. II Jun-02-2021
20 Elekta, Inc. II Jun-30-2020
21 Elekta, Inc. II Jun-05-2020
22 Klarity Medical Products LLC II Aug-24-2020
23 Landauer II Dec-22-2023
24 Landauer II Sep-12-2023
25 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
26 Med Tec Inc II Jun-02-2020
27 PTW NORTH AMERICA CORPORATION II Jan-11-2022
28 PTW-FREIBURG II Feb-22-2024
29 PTW-FREIBURG II Sep-11-2023
30 Reflexion Medical, Inc. II Jan-10-2022
31 Siemens Medical Solutions USA, Inc II Dec-09-2022
32 Siemens Medical Solutions USA, Inc II Dec-29-2021
33 Siemens Medical Solutions USA, Inc II Apr-07-2020
34 Siemens Medical Solutions USA, Inc II Feb-21-2020
35 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
36 Varian Medical Systems, Inc. II May-05-2020
37 Viewray, Inc. II Nov-20-2020
38 Viewray, Inc. II Apr-27-2020
39 Zap Surgical Systems II Sep-14-2022
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