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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device couch, radiation therapy, powered
Product CodeJAI
Regulation Number 892.5770
Device Class 2


Premarket Reviews
ManufacturerDecision
CHINAN BIOMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Alarm Not Visible 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 1 1
Head Injury 1 1
Nausea 1 1
Pain 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LEONI CIA CABLE SYSTEMS II Nov-21-2023
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