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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
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 118 118
Loss of Data 8 8
Application Program Problem: Dose Calculation Error 7 7
Improper or Incorrect Procedure or Method 6 6
Use of Device Problem 5 5
Program or Algorithm Execution Failure 5 5
Inadequate User Interface 4 4
Use of Incorrect Control/Treatment Settings 3 3
Application Program Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Optical Distortion 1 1
Protective Measures Problem 1 1
Application Program Problem: Medication Error 1 1
Non Reproducible Results 1 1
Application Program Version or Upgrade Problem 1 1
Computer Operating System Problem 1 1
Failure to Deliver 1 1
Failure to Align 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Device Alarm System 1 1
Incorrect Measurement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105 105
No Consequences Or Impact To Patient 16 16
Insufficient Information 13 13
No Information 11 11
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 10 10
Radiation Overdose 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Dehydration 1 1
Viral Infection 1 1
Overdose 1 1
Missing Value Reason 1 1
Hypoxia 1 1
Patient Problem/Medical Problem 1 1
Memory Loss/Impairment 1 1
Visual Disturbances 1 1
Cognitive Changes 1 1
Dry Mouth 1 1
Alteration in Body Temperature 1 1
Anxiety 1 1
Sleep Dysfunction 1 1
Spinal Column Injury 1 1
Radiation Burn 1 1
Burn(s) 1 1
Unintended Radiation Exposure 1 1
Tics/Tremor 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 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 LABORATORIES AB II Dec-23-2019
39 RAYSEARCH LABORATORIES AB II Jul-05-2019
40 RAYSEARCH LABORATORIES AB II Jul-03-2019
41 RaySearch America Inc II Jun-29-2023
42 RaySearch America Inc II Mar-31-2022
43 Siemens Medical Solutions USA, Inc II Apr-22-2022
44 Siemens Medical Solutions USA, Inc II Sep-10-2021
45 Siemens Medical Solutions USA, Inc II Sep-23-2020
46 Siemens Medical Solutions USA, Inc II Jul-22-2020
47 Varian Medical Systems, Inc. II Jan-24-2019
48 Viewray, Inc. II Jun-09-2021
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