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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Super Search Devices@FDA
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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
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
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
  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 1
PHILIPS OY
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 2
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAYSEARCH LABORATORIES AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA SAS
  SUBSTANTIALLY EQUIVALENT 2
UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
XSTRAHL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 26 26
2021 15 15
2022 22 22
2023 76 76
2024 9 9
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 109 109
Use of Device Problem 19 19
Application Program Problem: Dose Calculation Error 9 9
Loss of Data 8 8
Application Program Problem 6 6
Insufficient Information 6 6
Improper or Incorrect Procedure or Method 6 6
Program or Algorithm Execution Failure 5 5
Use of Incorrect Control/Treatment Settings 4 4
Inadequate User Interface 4 4
No Apparent Adverse Event 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Image Display Error/Artifact 1 1
Non Reproducible Results 1 1
Application Program Version or Upgrade Problem 1 1
Failure to Deliver 1 1
Optical Distortion 1 1
Misassembled During Installation 1 1
Failure to Align 1 1
Incorrect Measurement 1 1
Application Program Problem: Parameter Calculation Error 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 134 134
Insufficient Information 25 25
No Patient Involvement 8 8
No Consequences Or Impact To Patient 7 7
No Information 5 5
No Known Impact Or Consequence To Patient 3 3
Unintended Radiation Exposure 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Sleep Dysfunction 1 1
Dry Mouth 1 1
Brain Injury 1 1
Memory Loss/Impairment 1 1
Inflammation 1 1
Tics/Tremor 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
Anxiety 1 1
Nodule 1 1
Radiation Overdose 1 1
Radiation Burn 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bebig Isotopentechnik Gmbh II Dec-08-2023
2 Elekta Impac Software II Mar-26-2020
3 Elekta Inc II Mar-08-2023
4 Elekta Inc II Sep-24-2021
5 Elekta Inc II Sep-02-2021
6 Elekta Inc II Apr-29-2020
7 Elekta, Inc. II Dec-15-2022
8 Elekta, Inc. II Oct-28-2021
9 Philips Medical Systems (Cleveland) Inc II Sep-16-2025
10 Philips Medical Systems (Cleveland) Inc II Aug-01-2025
11 Philips Medical Systems (Cleveland) Inc II Sep-15-2022
12 RAYSEARCH LABORATORIES AB II Sep-02-2025
13 RAYSEARCH LABORATORIES AB II Feb-19-2025
14 RAYSEARCH LABORATORIES AB II May-01-2024
15 RAYSEARCH LABORATORIES AB II Apr-05-2024
16 RAYSEARCH LABORATORIES AB II Nov-01-2023
17 RAYSEARCH LABORATORIES AB II Aug-25-2023
18 RAYSEARCH LABORATORIES AB II Mar-22-2023
19 RAYSEARCH LABORATORIES AB II Jul-19-2022
20 RAYSEARCH LABORATORIES AB II Jun-28-2022
21 RAYSEARCH LABORATORIES AB II Mar-31-2022
22 RAYSEARCH LABORATORIES AB II Mar-31-2022
23 RAYSEARCH LABORATORIES AB II Mar-08-2022
24 RAYSEARCH LABORATORIES AB II Jul-23-2021
25 RAYSEARCH LABORATORIES AB II Jun-09-2021
26 RAYSEARCH LABORATORIES AB II May-14-2021
27 RAYSEARCH LABORATORIES AB II May-14-2021
28 RAYSEARCH LABORATORIES AB II Apr-15-2021
29 RAYSEARCH LABORATORIES AB II Mar-19-2021
30 RAYSEARCH LABORATORIES AB II Dec-15-2020
31 RAYSEARCH LABORATORIES AB II Nov-20-2020
32 RAYSEARCH LABORATORIES AB II Aug-27-2020
33 RAYSEARCH LABORATORIES AB II Jun-24-2020
34 RAYSEARCH LABORATORIES AB II Jun-10-2020
35 RAYSEARCH LABORATORIES AB II Mar-26-2020
36 RAYSEARCH LABORATORIES AB II Mar-10-2020
37 RAYSEARCH LABORATORIES AB II Jan-27-2020
38 RaySearch America Inc II Jun-29-2023
39 RaySearch America Inc II Mar-31-2022
40 Siemens Medical Solutions USA, Inc II Apr-22-2022
41 Siemens Medical Solutions USA, Inc II Sep-10-2021
42 Siemens Medical Solutions USA, Inc II Sep-23-2020
43 Siemens Medical Solutions USA, Inc II Jul-22-2020
44 Viewray, Inc. II Jun-09-2021
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