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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, radiation therapy, radionuclide
Product CodeIWB
Regulation Number 892.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
AKESIS INC
  SUBSTANTIALLY EQUIVALENT 3
ELEKTA INSTRUMENT AB
  SUBSTANTIALLY EQUIVALENT 2
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 2
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XCISION MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 4 4
2018 2 2
2019 3 3
2020 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 3 3
Misassembled 3 3
Electrical /Electronic Property Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Device Fell 1 1
Disconnection 1 1
Break 1 1
Insufficient Information 1 1
Fitting Problem 1 1
Application Program Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5 5
No Known Impact Or Consequence To Patient 4 4
No Information 1 1
Erythema 1 1
Necrosis 1 1
Rash 1 1
Seizures 1 1
Loss of Vision 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Elekta Instrument AB II May-23-2019
2 Elekta, Inc. II May-31-2017
3 Xcision Medical Systems, LLC II Jan-18-2024
4 Xcision Medical Systems, LLC II Jul-25-2019
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