• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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
Product CodeJAD
Regulation Number 892.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
NUCLETRON B.V.
  SUBSTANTIALLY EQUIVALENT 1
SENSUS HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
SENSUS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
XSTRAHL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9 9
2022 5 5
2023 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Patient Device Interaction Problem 5 5
Failure to Deliver Energy 1 1
Device Operational Issue 1 1
Output Problem 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inadequate Instructions for Healthcare Professional 1 1
Use of Device Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unexpected Therapeutic Results 1 1
Device Displays Incorrect Message 1 1
Unexpected/Unintended Radiation Output 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Sensus Healthcare, Inc. II Mar-08-2023
2 Xstrahl Limited II Dec-16-2021
3 Xstrahl Limited II Oct-26-2021
4 Xstrahl Limited II Jul-19-2022
-
-