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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, planning, radiation therapy treatment
Regulation Description Medical charged-particle radiation therapy system.
Product CodeMUJ
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
.DECIMAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
.DECIMAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ADAPTIIV
  SUBSTANTIALLY EQUIVALENT 1
ADAPTIIV MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEST NOMOS
  SUBSTANTIALLY EQUIVALENT 2
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 3
CARINA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 3
ELEKTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
  SUBSTANTIALLY EQUIVALENT 1
LIFELINE SOFTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANTEIA TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ONCOSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS MR FINLAND
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS OY
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 2
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAYSEARCH LABORATORIES AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 8
SENSUS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPECTRONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA SAS
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
  1.  K200608  Eclipse Treatment Planning System v16.0
  2.  K203469  AI Segmentation
  3.  K203766  4D Integrated Treatment Console
  4.  K211881  AI Segmentation
  5.  K230557  Eclipse Treatment Planning System (v18.0)
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K200608  Eclipse Treatment Planning System v16.0
  2.  K203469  AI Segmentation
  3.  K203766  4D Integrated Treatment Console
  4.  K211881  AI Segmentation
  5.  K230557  Eclipse Treatment Planning System (v18.0)
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K200608  Eclipse Treatment Planning System v16.0
  2.  K203469  AI Segmentation
  3.  K203766  4D Integrated Treatment Console
  4.  K211881  AI Segmentation
  5.  K230557  Eclipse Treatment Planning System (v18.0)
XSTRAHL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 26 26
2021 15 15
2022 22 22
2023 76 76
2024 9 9
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 124 124
Loss of Data 8 8
Use of Device Problem 7 7
Application Program Problem: Dose Calculation Error 7 7
Application Program Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Program or Algorithm Execution Failure 5 5
Inadequate User Interface 4 4
Use of Incorrect Control/Treatment Settings 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Application Program Problem: Parameter Calculation Error 1 1
Display or Visual Feedback Problem 1 1
Computer Operating System Problem 1 1
Non Reproducible Results 1 1
Application Program Version or Upgrade Problem 1 1
Failure to Deliver 1 1
Misassembled During Installation 1 1
Device Alarm System 1 1
Application Program Problem: Medication Error 1 1
Failure to Align 1 1
Protective Measures Problem 1 1
Optical Distortion 1 1
Incorrect Measurement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
No Apparent Adverse Event 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 115 115
Insufficient Information 17 17
No Consequences Or Impact To Patient 16 16
No Information 11 11
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Radiation Overdose 2 2
Overdose 1 1
Sleep Dysfunction 1 1
Burn(s) 1 1
Dry Mouth 1 1
Tics/Tremor 1 1
Visual Disturbances 1 1
Unintended Radiation Exposure 1 1
Alteration in Body Temperature 1 1
Missing Value Reason 1 1
Spinal Column Injury 1 1
Radiation Burn 1 1
Anxiety 1 1
Hypoxia 1 1
Cognitive Changes 1 1
Dehydration 1 1
Memory Loss/Impairment 1 1
Patient Problem/Medical Problem 1 1
Viral Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bebig Isotopentechnik Gmbh II Dec-08-2023
2 Brainlab AG II Apr-21-2019
3 Elekta Impac Software II Mar-26-2020
4 Elekta Inc II Mar-08-2023
5 Elekta Inc II Sep-24-2021
6 Elekta Inc II Sep-02-2021
7 Elekta Inc II Apr-29-2020
8 Elekta Inc II Dec-12-2019
9 Elekta Inc II Sep-25-2019
10 Elekta Inc II Jul-27-2019
11 Elekta, Inc. II Dec-15-2022
12 Elekta, Inc. II Oct-28-2021
13 Elekta, Inc. II Aug-28-2019
14 Elekta, Inc. II Feb-27-2019
15 Philips Medical Systems (Cleveland) Inc II Sep-15-2022
16 RAYSEARCH LABORATORIES AB II May-01-2024
17 RAYSEARCH LABORATORIES AB II Apr-05-2024
18 RAYSEARCH LABORATORIES AB II Nov-01-2023
19 RAYSEARCH LABORATORIES AB II Aug-25-2023
20 RAYSEARCH LABORATORIES AB II Mar-22-2023
21 RAYSEARCH LABORATORIES AB II Jul-19-2022
22 RAYSEARCH LABORATORIES AB II Jun-28-2022
23 RAYSEARCH LABORATORIES AB II Mar-31-2022
24 RAYSEARCH LABORATORIES AB II Mar-31-2022
25 RAYSEARCH LABORATORIES AB II Mar-08-2022
26 RAYSEARCH LABORATORIES AB II Jul-23-2021
27 RAYSEARCH LABORATORIES AB II Jun-09-2021
28 RAYSEARCH LABORATORIES AB II May-14-2021
29 RAYSEARCH LABORATORIES AB II May-14-2021
30 RAYSEARCH LABORATORIES AB II Apr-15-2021
31 RAYSEARCH LABORATORIES AB II Mar-19-2021
32 RAYSEARCH LABORATORIES AB II Dec-15-2020
33 RAYSEARCH LABORATORIES AB II Nov-20-2020
34 RAYSEARCH LABORATORIES AB II Aug-27-2020
35 RAYSEARCH LABORATORIES AB II Jun-24-2020
36 RAYSEARCH LABORATORIES AB II Jun-10-2020
37 RAYSEARCH LABORATORIES AB II Mar-26-2020
38 RAYSEARCH LABORATORIES AB II Mar-10-2020
39 RAYSEARCH LABORATORIES AB II Jan-27-2020
40 RAYSEARCH LABORATORIES AB II Dec-23-2019
41 RAYSEARCH LABORATORIES AB II Jul-05-2019
42 RAYSEARCH LABORATORIES AB II Jul-03-2019
43 RaySearch America Inc II Jun-29-2023
44 RaySearch America Inc II Mar-31-2022
45 Siemens Medical Solutions USA, Inc II Apr-22-2022
46 Siemens Medical Solutions USA, Inc II Sep-10-2021
47 Siemens Medical Solutions USA, Inc II Sep-23-2020
48 Siemens Medical Solutions USA, Inc II Jul-22-2020
49 Varian Medical Systems, Inc. II Jan-24-2019
50 Viewray, Inc. II Jun-09-2021
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