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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, telethermographic (adjunctive use)
Product CodeLHQ
Regulation Number 884.2980
Device Class 1


Premarket Reviews
ManufacturerDecision
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
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Calibration Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 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
Cancer 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Med-Hot Thermal Imaging, Inc. II May-09-2017
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