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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 2
ADAPTIIV
  SUBSTANTIALLY EQUIVALENT 1
ADAPTIIV MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BEST NOMOS
  SUBSTANTIALLY EQUIVALENT 2
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 4
CARINA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COSYLAB JSC, CONTROL SYSTEM LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
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
MVISION AI OY
  SUBSTANTIALLY EQUIVALENT 1
ONCOSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS MR FINLAND
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS OY
  SUBSTANTIALLY EQUIVALENT 1
PROWESS, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
RAYSEARCH LABORATORIES AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 11
SENSUS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
SPECTRONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA SAS
  SUBSTANTIALLY EQUIVALENT 3
UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
XSTRAHL, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 26 26
2021 15 16
2022 22 27
2023 76 76
2024 9 9
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 130 130
Use of Device Problem 20 20
Improper or Incorrect Procedure or Method 11 11
Application Program Problem: Dose Calculation Error 10 10
Loss of Data 8 14
Application Program Problem 6 6
Insufficient Information 6 6
Program or Algorithm Execution Failure 5 5
Use of Incorrect Control/Treatment Settings 4 4
Inadequate User Interface 4 4
Adverse Event Without Identified Device or Use Problem 3 3
No Apparent Adverse Event 3 3
Application Program Problem: Parameter Calculation Error 2 2
No Display/Image 1 1
Device Alarm System 1 1
Image Display Error/Artifact 1 1
Non Reproducible Results 1 1
Application Program Version or Upgrade Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Deliver 1 1
Optical Distortion 1 1
Misassembled During Installation 1 1
Failure to Align 1 1
Application Program Problem: Medication Error 1 1
Computer Operating System Problem 1 1
Incorrect Measurement 1 1
Protective Measures Problem 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 141 147
Insufficient Information 25 26
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
Unintended Radiation Exposure 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Radiation Overdose 2 2
Patient Problem/Medical Problem 1 1
Sleep Dysfunction 1 1
Dry Mouth 1 1
Brain Injury 1 1
Memory Loss/Impairment 1 1
Tics/Tremor 1 1
Inflammation 1 1
Cognitive Changes 1 1
Overdose 1 1
Spinal Column Injury 1 1
Burn(s) 1 1
Visual Disturbances 1 1
Viral Infection 1 1
Alteration in Body Temperature 1 1
Dehydration 1 1
Pain 1 1
Missing Value Reason 1 1
Anxiety 1 1
Nodule 1 1
Radiation Burn 1 1
Hypoxia 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 Feb-10-2026
12 Elekta, Inc. II Dec-15-2022
13 Elekta, Inc. II Oct-28-2021
14 Elekta, Inc. II Aug-28-2019
15 Elekta, Inc. II Feb-27-2019
16 Philips Medical Systems (Cleveland) Inc II Sep-16-2025
17 Philips Medical Systems (Cleveland) Inc II Aug-01-2025
18 Philips Medical Systems (Cleveland) Inc II Sep-15-2022
19 RAYSEARCH LABORATORIES AB II Jan-16-2026
20 RAYSEARCH LABORATORIES AB II Sep-02-2025
21 RAYSEARCH LABORATORIES AB II Feb-19-2025
22 RAYSEARCH LABORATORIES AB II May-01-2024
23 RAYSEARCH LABORATORIES AB II Apr-05-2024
24 RAYSEARCH LABORATORIES AB II Nov-01-2023
25 RAYSEARCH LABORATORIES AB II Aug-25-2023
26 RAYSEARCH LABORATORIES AB II Mar-22-2023
27 RAYSEARCH LABORATORIES AB II Jul-19-2022
28 RAYSEARCH LABORATORIES AB II Jun-28-2022
29 RAYSEARCH LABORATORIES AB II Mar-31-2022
30 RAYSEARCH LABORATORIES AB II Mar-31-2022
31 RAYSEARCH LABORATORIES AB II Mar-08-2022
32 RAYSEARCH LABORATORIES AB II Jul-23-2021
33 RAYSEARCH LABORATORIES AB II Jun-09-2021
34 RAYSEARCH LABORATORIES AB II May-14-2021
35 RAYSEARCH LABORATORIES AB II May-14-2021
36 RAYSEARCH LABORATORIES AB II Apr-15-2021
37 RAYSEARCH LABORATORIES AB II Mar-19-2021
38 RAYSEARCH LABORATORIES AB II Dec-15-2020
39 RAYSEARCH LABORATORIES AB II Nov-20-2020
40 RAYSEARCH LABORATORIES AB II Aug-27-2020
41 RAYSEARCH LABORATORIES AB II Jun-24-2020
42 RAYSEARCH LABORATORIES AB II Jun-10-2020
43 RAYSEARCH LABORATORIES AB II Mar-26-2020
44 RAYSEARCH LABORATORIES AB II Mar-10-2020
45 RAYSEARCH LABORATORIES AB II Jan-27-2020
46 RAYSEARCH LABORATORIES AB II Dec-23-2019
47 RAYSEARCH LABORATORIES AB II Jul-05-2019
48 RAYSEARCH LABORATORIES AB II Jul-03-2019
49 RaySearch America Inc II Jun-29-2023
50 RaySearch America Inc II Mar-31-2022
51 Siemens Medical Solutions USA, Inc II Apr-22-2022
52 Siemens Medical Solutions USA, Inc II Sep-10-2021
53 Siemens Medical Solutions USA, Inc II Sep-23-2020
54 Siemens Medical Solutions USA, Inc II Jul-22-2020
55 Varian Medical Systems, Inc. II Jan-24-2019
56 Viewray, Inc. II Jun-09-2021
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