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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
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
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
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 2
SPECTRONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 25 25
2020 26 26
2021 15 15
2022 22 22
2023 76 76
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 121 121
Loss of Data 8 8
Application Program Problem: Dose Calculation Error 7 7
Use of Device Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Program or Algorithm Execution Failure 5 5
Inadequate User Interface 4 4
Application Program Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Optical Distortion 1 1
Non Reproducible Results 1 1
Failure to Deliver 1 1
Incorrect Measurement 1 1
No Display/Image 1 1
Application Program Version or Upgrade Problem 1 1
Misassembled During Installation 1 1
Computer Operating System Problem 1 1
Protective Measures Problem 1 1
Application Program Problem: Medication Error 1 1
Display or Visual Feedback Problem 1 1
Failure to Align 1 1
Device Alarm System 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 107 107
Insufficient Information 16 16
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
Radiation Burn 1 1
Burn(s) 1 1
Dehydration 1 1
Hypoxia 1 1
Memory Loss/Impairment 1 1
Overdose 1 1
Spinal Column Injury 1 1
Visual Disturbances 1 1
Missing Value Reason 1 1
Tics/Tremor 1 1
Dry Mouth 1 1
Unintended Radiation Exposure 1 1
Alteration in Body Temperature 1 1
Viral Infection 1 1
Anxiety 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Patient Problem/Medical Problem 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 Apr-05-2024
17 RAYSEARCH LABORATORIES AB II Nov-01-2023
18 RAYSEARCH LABORATORIES AB II Aug-25-2023
19 RAYSEARCH LABORATORIES AB II Mar-22-2023
20 RAYSEARCH LABORATORIES AB II Jul-19-2022
21 RAYSEARCH LABORATORIES AB II Jun-28-2022
22 RAYSEARCH LABORATORIES AB II Mar-31-2022
23 RAYSEARCH LABORATORIES AB II Mar-31-2022
24 RAYSEARCH LABORATORIES AB II Mar-08-2022
25 RAYSEARCH LABORATORIES AB II Jul-23-2021
26 RAYSEARCH LABORATORIES AB II Jun-09-2021
27 RAYSEARCH LABORATORIES AB II May-14-2021
28 RAYSEARCH LABORATORIES AB II May-14-2021
29 RAYSEARCH LABORATORIES AB II Apr-15-2021
30 RAYSEARCH LABORATORIES AB II Mar-19-2021
31 RAYSEARCH LABORATORIES AB II Dec-15-2020
32 RAYSEARCH LABORATORIES AB II Nov-20-2020
33 RAYSEARCH LABORATORIES AB II Aug-27-2020
34 RAYSEARCH LABORATORIES AB II Jun-24-2020
35 RAYSEARCH LABORATORIES AB II Jun-10-2020
36 RAYSEARCH LABORATORIES AB II Mar-26-2020
37 RAYSEARCH LABORATORIES AB II Mar-10-2020
38 RAYSEARCH LABORATORIES AB II Jan-27-2020
39 RAYSEARCH LABORATORIES AB II Dec-23-2019
40 RAYSEARCH LABORATORIES AB II Jul-05-2019
41 RAYSEARCH LABORATORIES AB II Jul-03-2019
42 RaySearch America Inc II Jun-29-2023
43 RaySearch America Inc II Mar-31-2022
44 Siemens Medical Solutions USA, Inc II Apr-22-2022
45 Siemens Medical Solutions USA, Inc II Sep-10-2021
46 Siemens Medical Solutions USA, Inc II Sep-23-2020
47 Siemens Medical Solutions USA, Inc II Jul-22-2020
48 Varian Medical Systems, Inc. II Jan-24-2019
49 Viewray, Inc. II Jun-09-2021
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