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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 2
BLESSING CATHAY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 5
BRAINLAB SE
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARINA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DOSEOPTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DOSISOFT SA
  SUBSTANTIALLY EQUIVALENT 1
ELECTROGENICS LABS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
KALLISIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 1
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 1
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PANACEA MEDICAL TECHNOLOGIES PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
PAPRICALAB
  SUBSTANTIALLY EQUIVALENT 1
PROWESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN DR. PYCHLA
  SUBSTANTIALLY EQUIVALENT 1
QFIX
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 18
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VISION RT, LTD.
  SUBSTANTIALLY EQUIVALENT 5
WISDOM TECHNOLOGIES., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 68 69
2022 66 66
2023 128 128
2024 81 81
2025 101 101
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 248 248
Adverse Event Without Identified Device or Use Problem 21 21
Imprecision 18 18
Unintended System Motion 16 16
Use of Device Problem 15 15
Detachment of Device or Device Component 12 12
Device Handling Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Unstable 9 9
Fluid/Blood Leak 6 6
Off-Label Use 6 6
No Apparent Adverse Event 6 6
Unintended Movement 6 6
Insufficient Information 6 6
Material Deformation 6 6
Communication or Transmission Problem 5 6
Protective Measures Problem 4 5
Output Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Therapy Delivered to Incorrect Body Area 3 3
Intermittent Communication Failure 3 3
Electrical /Electronic Property Problem 3 3
Break 3 3
Grounding Malfunction 3 3
Mechanical Problem 3 3
Low impedance 3 3
Calibration Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Material Too Soft/Flexible 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
Program or Algorithm Execution Problem 2 2
Circuit Failure 2 2
Radiation Overexposure 2 2
Device Fell 2 2
Patient-Device Incompatibility 2 2
Inadequate User Interface 1 1
Arcing of Electrodes 1 1
Unintended Collision 1 1
Disconnection 1 1
Failure to Discharge 1 1
Failure to Read Input Signal 1 1
Mechanical Jam 1 1
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1
Display or Visual Feedback Problem 1 1
Improper Chemical Reaction 1 1
Computer System Security Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 288 288
Insufficient Information 286 287
Unintended Radiation Exposure 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Bone Fracture(s) 7 7
Incontinence 4 4
Fall 2 2
Limb Fracture 2 2
Ulcer 2 2
Foreign Body In Patient 2 2
Cancer 2 2
Crushing Injury 2 2
Abrasion 2 2
Radiation Burn 2 2
Laceration(s) 2 2
Local Reaction 2 2
Vomiting 1 1
Dysphasia 1 1
Brain Injury 1 1
Hernia 1 1
Viral Infection 1 1
Nausea 1 1
Necrosis 1 1
Nerve Damage 1 1
Neuropathy 1 1
Pleural Effusion 1 1
Burn(s) 1 1
Atrial Fibrillation 1 1
Dehydration 1 1
Diarrhea 1 1
Head Injury 1 1
Hemorrhage/Bleeding 1 1
Constipation 1 1
Melena 1 1
Joint Dislocation 1 1
Neck Pain 1 1
Respiratory Failure 1 1
Ambulation Difficulties 1 1
Electric Shock 1 1
No Patient Involvement 1 1
Unspecified Infection 1 1
Inflammation 1 1
Decreased Appetite 1 1
Swelling/ Edema 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 Jan-14-2026
10 C-RAD POSITIONING AB II May-28-2025
11 C-RAD POSITIONING AB II Jul-14-2021
12 Carbon Medical Technologies, Inc. III Sep-17-2024
13 ELEKTA SOLUTIONS AB II Nov-14-2025
14 ELEKTA SOLUTIONS AB II Oct-14-2021
15 Elekta, Inc. II Jan-23-2026
16 Elekta, Inc. II Jan-13-2026
17 Elekta, Inc. II Feb-12-2025
18 Elekta, Inc. II Dec-01-2023
19 Elekta, Inc. II Jun-02-2023
20 Elekta, Inc. II May-30-2023
21 Elekta, Inc. II Oct-14-2021
22 Elekta, Inc. II Sep-29-2021
23 Elekta, Inc. II Jun-02-2021
24 IBA Dosimetry GmbH II Apr-30-2025
25 Landauer II Dec-22-2023
26 Landauer II Sep-12-2023
27 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
28 PTW NORTH AMERICA CORPORATION II Jan-11-2022
29 PTW-FREIBURG II Feb-22-2024
30 PTW-FREIBURG II Sep-11-2023
31 Reflexion Medical, Inc. II Jan-10-2022
32 Siemens Medical Solutions USA, Inc II Dec-09-2022
33 Siemens Medical Solutions USA, Inc II Dec-29-2021
34 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
35 Zap Surgical Systems II Sep-26-2025
36 Zap Surgical Systems II Sep-14-2022
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