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TPLC
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show TPLC since
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2011
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2024
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Device
system, therapeutic, x-ray
Product Code
JAD
Regulation Number
892.5900
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Output Problem
2
2
Device Operational Issue
2
2
Insufficient Information
2
2
Radiation Overexposure
2
2
Failure to Deliver Energy
1
1
Radiation Underexposure
1
1
Deflation Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Use of Device Problem
1
1
Failure to Align
1
1
Incorrect Measurement
1
1
Unexpected Therapeutic Results
1
1
Burst Container or Vessel
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Integrity Problem
1
1
Positioning Problem
1
1
Calibration Problem
1
1
Material Rupture
1
1
Inflation Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Appropriate Term/Code Not Available
1
1
Inaccurate Delivery
1
1
Device Operates Differently Than Expected
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
Hair Loss
1
1
Radiation Underdose
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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