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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 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 3
CARINA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COSYLAB JSC, CONTROL SYSTEM LABORATORY
  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 OY
  SUBSTANTIALLY EQUIVALENT 1
PROWESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAYSEARCH LABORATORIES AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 5
XSTRAHL, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 97 97
Use of Device Problem 13 13
Application Program Problem: Dose Calculation Error 8 8
Loss of Data 8 14
Insufficient Information 6 6
Application Program Problem 5 5
Program or Algorithm Execution Failure 5 5
Improper or Incorrect Procedure or Method 5 5
Use of Incorrect Control/Treatment Settings 4 4
Inadequate User Interface 4 4
No Apparent Adverse Event 3 3
Image Display Error/Artifact 1 1
Non Reproducible Results 1 1
Application Program Version or Upgrade Problem 1 1
Misassembled During Installation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1
Application Program Problem: Parameter Calculation Error 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 137
Insufficient Information 25 26
Unintended Radiation Exposure 5 5
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
Spinal Column Injury 1 1
Visual Disturbances 1 1
Viral Infection 1 1
Alteration in Body Temperature 1 1
Pain 1 1
Anxiety 1 1
Nodule 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bebig Isotopentechnik Gmbh II Dec-08-2023
2 Elekta Inc II Mar-08-2023
3 Elekta Inc II Sep-24-2021
4 Elekta Inc II Sep-02-2021
5 Elekta, Inc. II Dec-15-2022
6 Elekta, Inc. II Oct-28-2021
7 Philips Medical Systems (Cleveland) Inc II Sep-16-2025
8 Philips Medical Systems (Cleveland) Inc II Aug-01-2025
9 Philips Medical Systems (Cleveland) Inc II Sep-15-2022
10 RAYSEARCH LABORATORIES AB II Jan-16-2026
11 RAYSEARCH LABORATORIES AB II Sep-02-2025
12 RAYSEARCH LABORATORIES AB II Feb-19-2025
13 RAYSEARCH LABORATORIES AB II May-01-2024
14 RAYSEARCH LABORATORIES AB II Apr-05-2024
15 RAYSEARCH LABORATORIES AB II Nov-01-2023
16 RAYSEARCH LABORATORIES AB II Aug-25-2023
17 RAYSEARCH LABORATORIES AB II Mar-22-2023
18 RAYSEARCH LABORATORIES AB II Jul-19-2022
19 RAYSEARCH LABORATORIES AB II Jun-28-2022
20 RAYSEARCH LABORATORIES AB II Mar-31-2022
21 RAYSEARCH LABORATORIES AB II Mar-31-2022
22 RAYSEARCH LABORATORIES AB II Mar-08-2022
23 RAYSEARCH LABORATORIES AB II Jul-23-2021
24 RAYSEARCH LABORATORIES AB II Jun-09-2021
25 RAYSEARCH LABORATORIES AB II May-14-2021
26 RAYSEARCH LABORATORIES AB II May-14-2021
27 RAYSEARCH LABORATORIES AB II Apr-15-2021
28 RAYSEARCH LABORATORIES AB II Mar-19-2021
29 RaySearch America Inc II Jun-29-2023
30 RaySearch America Inc II Mar-31-2022
31 Siemens Medical Solutions USA, Inc II Apr-22-2022
32 Siemens Medical Solutions USA, Inc II Sep-10-2021
33 Viewray, Inc. II Jun-09-2021
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