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TPLC
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Device
system, telethermographic (adjunctive use)
Product Code
LHQ
Regulation Number
884.2980
Device Class
1
Premarket Reviews
Manufacturer
Decision
AG DIGITAL TECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
1
ALFA THERMODIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
FIRST SENSE MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
2
INTOUCH TECHNOLOGIES, INC., D.B.A. INTOUCH HEALTH
SUBSTANTIALLY EQUIVALENT
1
MED-HOT THERMAL IMAGING INC.
SUBSTANTIALLY EQUIVALENT
1
MEDICORE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
THERMIDAS AMERICAS, INC.
SUBSTANTIALLY EQUIVALENT
1
UE LIFESCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
1
USA THERM, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
1
1
2021
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Therapeutic or Diagnostic Output Failure
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Calibration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Breast Cancer
1
1
No Known Impact Or Consequence To Patient
1
1
Insufficient Information
1
1
Cancer
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Med-Hot Thermal Imaging, Inc.
II
May-09-2017
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