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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 2
3D BOLUS, INC.
  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
ELEKTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFELINE SOFTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOM GMBH
  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 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAYSEARCH LABORATORIES AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 9
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
UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2018 25 25
2019 25 25
2020 26 26
2021 16 16
2022 21 21
2023 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 123 123
Improper or Incorrect Procedure or Method 8 8
Application Program Problem: Dose Calculation Error 7 7
Loss of Data 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Program or Algorithm Execution Failure 5 5
Inadequate User Interface 4 4
Use of Device Problem 4 4
Use of Incorrect Control/Treatment Settings 4 4
Nonstandard Device 3 3
Application Program Problem 3 3
Defective Component 2 2
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Application Program Problem: Medication Error 1 1
Non Reproducible Results 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Optical Distortion 1 1
Misassembled During Installation 1 1
Failure to Deliver 1 1
Failure to Align 1 1
Application Program Version or Upgrade Problem 1 1
Computer Operating System Problem 1 1
Device Operates Differently Than Expected 1 1
Product Quality Problem 1 1
Device Alarm System 1 1
No Display/Image 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 92 92
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 15 15
No Information 14 14
No Patient Involvement 13 13
Insufficient Information 11 11
Radiation Overdose 7 7
Radiation Burn 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Dehydration 1 1
Exsanguination 1 1
Ulceration 1 1
Viral Infection 1 1
Loss of consciousness 1 1
Respiratory Failure 1 1
Missing Value Reason 1 1
Hypoxia 1 1
Overdose 1 1
Patient Problem/Medical Problem 1 1
Memory Loss/Impairment 1 1
Visual Disturbances 1 1
Cognitive Changes 1 1
Unspecified Infection 1 1
Loss Of Pulse 1 1
Burn(s) 1 1
Swelling 1 1
Radiation Underdose 1 1
Unintended Radiation Exposure 1 1
Death 1 1
Tics/Tremor 1 1
Anxiety 1 1
Radiation Exposure, Unintended 1 1
Dry Mouth 1 1
Alteration in Body Temperature 1 1
Sleep Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG II Apr-21-2019
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-12-2019
8 Elekta Inc II Sep-25-2019
9 Elekta Inc II Jul-27-2019
10 Elekta, Inc. II Dec-15-2022
11 Elekta, Inc. II Oct-28-2021
12 Elekta, Inc. II Aug-28-2019
13 Elekta, Inc. II Feb-27-2019
14 Philips Medical Systems (Cleveland) Inc II Sep-15-2022
15 RAYSEARCH LABORATORIES AB II Mar-22-2023
16 RAYSEARCH LABORATORIES AB II Jul-19-2022
17 RAYSEARCH LABORATORIES AB II Jun-28-2022
18 RAYSEARCH LABORATORIES AB II Mar-31-2022
19 RAYSEARCH LABORATORIES AB II Mar-31-2022
20 RAYSEARCH LABORATORIES AB II Mar-08-2022
21 RAYSEARCH LABORATORIES AB II Jul-23-2021
22 RAYSEARCH LABORATORIES AB II Jun-09-2021
23 RAYSEARCH LABORATORIES AB II May-14-2021
24 RAYSEARCH LABORATORIES AB II May-14-2021
25 RAYSEARCH LABORATORIES AB II Apr-15-2021
26 RAYSEARCH LABORATORIES AB II Mar-19-2021
27 RAYSEARCH LABORATORIES AB II Dec-15-2020
28 RAYSEARCH LABORATORIES AB II Nov-20-2020
29 RAYSEARCH LABORATORIES AB II Aug-27-2020
30 RAYSEARCH LABORATORIES AB II Jun-24-2020
31 RAYSEARCH LABORATORIES AB II Jun-10-2020
32 RAYSEARCH LABORATORIES AB II Mar-26-2020
33 RAYSEARCH LABORATORIES AB II Mar-10-2020
34 RAYSEARCH LABORATORIES AB II Jan-27-2020
35 RAYSEARCH LABORATORIES AB II Dec-23-2019
36 RAYSEARCH LABORATORIES AB II Jul-05-2019
37 RAYSEARCH LABORATORIES AB II Jul-03-2019
38 RAYSEARCH LABORATORIES AB II Oct-30-2018
39 RAYSEARCH LABORATORIES AB II Jul-26-2018
40 RAYSEARCH LABORATORIES AB II Jul-19-2018
41 RAYSEARCH LABORATORIES AB II Jun-26-2018
42 RAYSEARCH LABORATORIES AB II Mar-29-2018
43 RAYSEARCH LABORATORIES AB II Jan-17-2018
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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