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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 3
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 2
LINATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 4
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
  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 6
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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 252 252
Imprecision 18 18
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
Unintended Movement 9 9
Fluid/Blood Leak 9 9
Unstable 9 9
Device Handling Problem 8 8
Communication or Transmission Problem 7 7
Insufficient Information 6 6
No Apparent Adverse Event 6 6
Off-Label Use 6 6
Material Deformation 6 6
Break 6 6
Improper or Incorrect Procedure or Method 5 5
Therapeutic or Diagnostic Output Failure 4 4
Data Problem 4 4
Protective Measures Problem 4 4
Unintended Collision 4 4
Output Problem 4 4
Mechanical Problem 4 4
Device Fell 4 4
Electrical /Electronic Property Problem 4 4
Therapy Delivered to Incorrect Body Area 3 3
Calibration Problem 3 3
Intermittent Communication Failure 3 3
Use of Incorrect Control/Treatment Settings 3 3
Appropriate Term/Code Not Available 2 2
Radiation Overexposure 2 2
Positioning Problem 2 2
Material Too Soft/Flexible 2 2
Program or Algorithm Execution Problem 2 2
Application Program Problem: Dose Calculation Error 2 2
Disconnection 2 2
Circuit Failure 2 2
Grounding Malfunction 2 2
Defective Component 2 2
Low impedance 2 2
Inadequate or Insufficient Training 2 2
Labelling, Instructions for Use or Training Problem 2 2
Installation-Related Problem 2 2
Compatibility Problem 2 2
Loss of Data 2 2
Product Quality Problem 2 2
Application Network Problem 2 2
Patient-Device Incompatibility 2 2
Failure to Recalibrate 2 2
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 277 277
Insufficient Information 263 263
No Information 24 24
No Consequences Or Impact To Patient 16 16
Unintended Radiation Exposure 14 14
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
Laceration(s) 2 2
Cancer 2 2
Local Reaction 2 2
Foreign Body In Patient 2 2
Limb Fracture 2 2
Radiation Burn 2 2
Crushing Injury 2 2
Melena 1 1
Constipation 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1
Swelling/ Edema 1 1
Decreased Appetite 1 1
Inflammation 1 1
Unspecified Infection 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Head Injury 1 1
Fall 1 1
Diarrhea 1 1
Dehydration 1 1
Burn(s) 1 1
Atrial Fibrillation 1 1
Radiation Overdose 1 1
Ambulation Difficulties 1 1
Respiratory Failure 1 1
Neck Pain 1 1
Joint Dislocation 1 1
Ulcer 1 1
Radiodermatitis 1 1
Viral Infection 1 1
Hernia 1 1
Brain Injury 1 1
Dysphasia 1 1
Radiation Underdose 1 1
Pleural Effusion 1 1
Neuropathy 1 1
Nerve Damage 1 1
Necrosis 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 May-28-2025
10 C-RAD POSITIONING AB II Jul-14-2021
11 Carbon Medical Technologies, Inc. III Sep-17-2024
12 ELEKTA SOLUTIONS AB II Oct-14-2021
13 Elekta Limited II Jun-08-2020
14 Elekta, Inc. II Feb-12-2025
15 Elekta, Inc. II Dec-01-2023
16 Elekta, Inc. II Jun-02-2023
17 Elekta, Inc. II May-30-2023
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 IBA Dosimetry GmbH II Apr-30-2025
24 Klarity Medical Products LLC II Aug-24-2020
25 Landauer II Dec-22-2023
26 Landauer II Sep-12-2023
27 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
28 Med Tec Inc II Jun-02-2020
29 PTW NORTH AMERICA CORPORATION II Jan-11-2022
30 PTW-FREIBURG II Feb-22-2024
31 PTW-FREIBURG II Sep-11-2023
32 Reflexion Medical, Inc. II Jan-10-2022
33 Siemens Medical Solutions USA, Inc II Dec-09-2022
34 Siemens Medical Solutions USA, Inc II Dec-29-2021
35 Siemens Medical Solutions USA, Inc II Apr-07-2020
36 Siemens Medical Solutions USA, Inc II Feb-21-2020
37 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
38 Varian Medical Systems, Inc. II May-05-2020
39 Viewray, Inc. II Nov-20-2020
40 Viewray, Inc. II Apr-27-2020
41 Zap Surgical Systems II Sep-14-2022
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