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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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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, therapeutic, x-ray
Regulation Description X-ray radiation therapy system.
Product CodeJAD
Regulation Number 892.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICAD INC.
  SUBSTANTIALLY EQUIVALENT 1
SENSUS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
XSTRAHL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 5 5
2016 5 5
2017 3 3
2018 1 1
2019 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Patient Device Interaction Problem 4 4
Balloon 3 3
Device Displays Incorrect Message 3 3
Radiation Overexposure 2 2
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Positioning Problem 1 1
Deflation Problem 1 1
Failure to Deliver Energy 1 1
Fluid Leak 1 1
Inflation Problem 1 1
Incorrect Measurement 1 1
Inaccurate Delivery 1 1
Failure to Align 1 1
Calibration Problem 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tissue Damage 6 6
Tissue Breakdown 6 6
Radiation Exposure, Unintended 4 4
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 3 3
No Code Available 2 2
No Information 1 1
Radiation Underdose 1 1
Radiation Burn 1 1
Breast Cancer 1 1
Edema 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Oct-02-2017
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