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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, therapeutic, x-ray
Product CodeJAD
Regulation Number 892.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS SURGICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
ICAD INC.
  SUBSTANTIALLY EQUIVALENT 1
ICAD, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUCLETRON B.V.
  SUBSTANTIALLY EQUIVALENT 2
SENSUS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
SENSUS HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
SENSUS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
XOFT, AN ICAD COMPANY
  SUBSTANTIALLY EQUIVALENT 1
XOFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 1
XSTRAHL LTD
  SUBSTANTIALLY EQUIVALENT 1
XSTRAHL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 5 5
2016 5 5
2017 3 3
2018 1 1
2019 9 9
2022 5 5
2023 2 2
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Patient Device Interaction Problem 5 5
Device Displays Incorrect Message 3 3
Device Operational Issue 2 2
Output Problem 2 2
Insufficient Information 2 2
Radiation Overexposure 2 2
Failure to Deliver Energy 1 1
Radiation Underexposure 1 1
Burst Container or Vessel 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Deflation Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Use of Incorrect Control/Treatment Settings 1 1
Inflation Problem 1 1
Material Rupture 1 1
Calibration Problem 1 1
Incorrect Measurement 1 1
Inaccurate Delivery 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Unexpected/Unintended Radiation Output 1 1
Fluid/Blood Leak 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tissue Breakdown 8 8
Tissue Damage 6 6
Breast Cancer 4 4
Radiation Exposure, Unintended 4 4
No Known Impact Or Consequence To Patient 4 4
Radiation Burn 4 4
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Pain 3 3
Cancer 3 3
No Code Available 2 2
Insufficient Information 2 2
Ulcer 2 2
Unspecified Vascular Problem 2 2
No Information 1 1
Edema 1 1
Nerve Damage 1 1
Radiation Underdose 1 1
Hair Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Action Products Incorporated II Sep-22-2009
2 Carl Zeiss Meditec AG II Oct-02-2017
3 Carl Zeiss Meditec, Inc. II Nov-20-2012
4 Carl Zeiss Meditec, Inc. II Aug-10-2011
5 Sensus Healthcare, Inc. II Mar-08-2023
6 Xstrahl Limited II Dec-16-2021
7 Xstrahl Limited II Oct-26-2021
8 Xstrahl Limited II Jul-19-2022
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