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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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New Search show TPLC since Back to Search Results
Device system, radiation therapy, radionuclide
Regulation Description Radionuclide radiation therapy system.
Product CodeIWB
Regulation Number 892.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
AKESIS INC
  SUBSTANTIALLY EQUIVALENT 2
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 3
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2023 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 2 2
Electrical /Electronic Property Problem 2 2
Break 1 1
Insufficient Information 1 1
Device Fell 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2 2
Fatigue 1 1
Necrosis 1 1
Dizziness 1 1
Muscle Weakness 1 1
Chills 1 1
Insufficient Information 1 1
Dyspnea 1 1
Dysphagia/ Odynophagia 1 1
Loss of Vision 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Xcision Medical Systems, LLC II Jan-18-2024
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