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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
BLESSING CATHAY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
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
ELECTROGENICS LABS, LTD.
  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 2
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 2
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 17
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VISION RT, LTD.
  SUBSTANTIALLY EQUIVALENT 6
WISDOM TECHNOLOGIES., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 74 74
2021 68 69
2022 66 66
2023 128 128
2024 81 81
2025 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 282 282
Adverse Event Without Identified Device or Use Problem 22 22
Imprecision 18 18
Use of Device Problem 18 18
Unintended System Motion 16 16
Detachment of Device or Device Component 16 16
Device Handling Problem 11 11
Fluid/Blood Leak 9 9
Unstable 9 9
Unintended Movement 9 9
Improper or Incorrect Procedure or Method 8 8
Insufficient Information 8 8
Communication or Transmission Problem 7 8
No Apparent Adverse Event 7 7
Break 6 6
Off-Label Use 6 6
Material Deformation 6 6
Unintended Collision 4 4
Electrical /Electronic Property Problem 4 4
Mechanical Problem 4 4
Output Problem 4 4
Protective Measures Problem 4 5
Device Fell 4 4
Data Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Therapy Delivered to Incorrect Body Area 3 3
Intermittent Communication Failure 3 3
Grounding Malfunction 3 3
Low impedance 3 3
Calibration Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Material Too Soft/Flexible 2 2
Application Network Problem 2 2
Inadequate or Insufficient Training 2 2
Appropriate Term/Code Not Available 2 2
Inaccurate Delivery 2 2
Installation-Related Problem 2 2
Product Quality Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Application Program Problem: Dose Calculation Error 2 2
Program or Algorithm Execution Problem 2 2
Circuit Failure 2 2
Disconnection 2 2
Radiation Overexposure 2 2
Positioning Problem 2 2
Defective Component 2 2
Compatibility Problem 2 2
Failure to Recalibrate 2 2
Patient-Device Incompatibility 2 2
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 314 314
Insufficient Information 293 294
Unintended Radiation Exposure 31 31
No Information 24 24
No Consequences Or Impact To Patient 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 9 9
Bone Fracture(s) 7 7
Incontinence 4 4
Abrasion 3 3
Cancer 2 2
Ulcer 2 2
Radiation Burn 2 2
Head Injury 2 2
Crushing Injury 2 2
Local Reaction 2 2
Limb Fracture 2 2
Foreign Body In Patient 2 2
Fall 2 2
Laceration(s) 2 2
Decreased Appetite 1 1
Ambulation Difficulties 1 1
Respiratory Failure 1 1
Hemorrhage/Bleeding 1 1
Constipation 1 1
Headache 1 1
Radiation Overdose 1 1
Swelling/ Edema 1 1
Dehydration 1 1
Radiation Underdose 1 1
Radiodermatitis 1 1
Vomiting 1 1
Viral Infection 1 1
Hernia 1 1
Pleural Effusion 1 1
Diarrhea 1 1
Nerve Damage 1 1
Neck Pain 1 1
Burn(s) 1 1
Atrial Fibrillation 1 1
Inflammation 1 1
Necrosis 1 1
Nausea 1 1
Brain Injury 1 1
No Code Available 1 1
Electric Shock 1 1
Joint Dislocation 1 1
Melena 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 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 Nov-14-2025
13 ELEKTA SOLUTIONS AB II Oct-14-2021
14 Elekta Limited II Jun-08-2020
15 Elekta, Inc. II Feb-12-2025
16 Elekta, Inc. II Dec-01-2023
17 Elekta, Inc. II Jun-02-2023
18 Elekta, Inc. II May-30-2023
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 IBA Dosimetry GmbH II Apr-30-2025
25 Klarity Medical Products LLC II Aug-24-2020
26 Landauer II Dec-22-2023
27 Landauer II Sep-12-2023
28 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
29 Med Tec Inc II Jun-02-2020
30 PTW NORTH AMERICA CORPORATION II Jan-11-2022
31 PTW-FREIBURG II Feb-22-2024
32 PTW-FREIBURG II Sep-11-2023
33 Reflexion Medical, Inc. II Jan-10-2022
34 Siemens Medical Solutions USA, Inc II Dec-09-2022
35 Siemens Medical Solutions USA, Inc II Dec-29-2021
36 Siemens Medical Solutions USA, Inc II Apr-07-2020
37 Siemens Medical Solutions USA, Inc II Feb-21-2020
38 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
39 Varian Medical Systems, Inc. II May-05-2020
40 Viewray, Inc. II Nov-20-2020
41 Viewray, Inc. II Apr-27-2020
42 Zap Surgical Systems II Sep-26-2025
43 Zap Surgical Systems II Sep-14-2022
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