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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 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 1
ELEKTA, INC
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
  SUBSTANTIALLY EQUIVALENT 1
LIFELINE SOFTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 1
ONCOSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS MR FINLAND
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS OY
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAYSEARCH LABORATORIES AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 10
SENSUS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2017 16 16
2018 25 25
2019 25 25
2020 26 26
2021 15 15
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 66 66
Improper or Incorrect Procedure or Method 9 9
Application Program Problem: Dose Calculation Error 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Nonstandard Device 5 5
Use of Device Problem 2 2
Defective Component 2 2
Application Program Problem 2 2
Device Operates Differently Than Expected 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Application Program Problem: Medication Error 1 1
Optical Distortion 1 1
Protective Measures Problem 1 1
Manufacturing, Packaging or Shipping Problem 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
Device Alarm System 1 1
Product Quality Problem 1 1
Use of Incorrect Control Settings 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 Consequences Or Impact To Patient 24 24
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 16 16
No Clinical Signs, Symptoms or Conditions 15 15
No Information 14 14
Radiation Overdose 9 9
Insufficient Information 8 8
Death 4 4
Pleural Effusion 2 2
Radiation Burn 2 2
Respiratory Failure 2 2
Cancer 2 2
Unintended Radiation Exposure 1 1
No Code Available 1 1
Missing Value Reason 1 1
Radiation Exposure, Unintended 1 1
Loss Of Pulse 1 1
Patient Problem/Medical Problem 1 1
Burn(s) 1 1
Loss of consciousness 1 1
Swelling 1 1
Ulceration 1 1
Radiation Underdose 1 1
Dehydration 1 1
Dyspnea 1 1
Exsanguination 1 1
Unspecified Infection 1 1
Overdose 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 Sep-24-2021
4 Elekta Inc II Sep-02-2021
5 Elekta Inc II Apr-29-2020
6 Elekta Inc II Dec-12-2019
7 Elekta Inc II Sep-25-2019
8 Elekta Inc II Jul-27-2019
9 Elekta Inc II Dec-13-2017
10 Elekta, Inc. II Oct-28-2021
11 Elekta, Inc. II Aug-28-2019
12 Elekta, Inc. II Feb-27-2019
13 Elekta, Inc. II Jan-18-2017
14 Elekta, Inc. II Jan-11-2017
15 Elekta, Inc. II Jan-10-2017
16 Nucletron BV II Oct-26-2017
17 RAYSEARCH LABORATORIES AB II Mar-31-2022
18 RAYSEARCH LABORATORIES AB II Mar-31-2022
19 RAYSEARCH LABORATORIES AB II Mar-08-2022
20 RAYSEARCH LABORATORIES AB II Jul-23-2021
21 RAYSEARCH LABORATORIES AB II Jun-09-2021
22 RAYSEARCH LABORATORIES AB II May-14-2021
23 RAYSEARCH LABORATORIES AB II May-14-2021
24 RAYSEARCH LABORATORIES AB II Apr-15-2021
25 RAYSEARCH LABORATORIES AB II Mar-19-2021
26 RAYSEARCH LABORATORIES AB II Dec-15-2020
27 RAYSEARCH LABORATORIES AB II Nov-20-2020
28 RAYSEARCH LABORATORIES AB II Aug-27-2020
29 RAYSEARCH LABORATORIES AB II Jun-24-2020
30 RAYSEARCH LABORATORIES AB II Jun-10-2020
31 RAYSEARCH LABORATORIES AB II Mar-26-2020
32 RAYSEARCH LABORATORIES AB II Mar-10-2020
33 RAYSEARCH LABORATORIES AB II Jan-27-2020
34 RAYSEARCH LABORATORIES AB II Dec-23-2019
35 RAYSEARCH LABORATORIES AB II Jul-05-2019
36 RAYSEARCH LABORATORIES AB II Jul-03-2019
37 RAYSEARCH LABORATORIES AB II Oct-30-2018
38 RAYSEARCH LABORATORIES AB II Jul-26-2018
39 RAYSEARCH LABORATORIES AB II Jul-19-2018
40 RAYSEARCH LABORATORIES AB II Jun-26-2018
41 RAYSEARCH LABORATORIES AB II Mar-29-2018
42 RAYSEARCH LABORATORIES AB II Jan-17-2018
43 RAYSEARCH LABORATORIES AB II Apr-12-2017
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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