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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device camera, ophthalmic, ac-powered
Regulation Description Ophthalmic camera.
Product CodeHKI
Regulation Number 886.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
AI OPTICS
  SUBSTANTIALLY EQUIVALENT 1
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALVUE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FORUS HEALTH PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
HUVITZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUNEAU TECHNOLOGY OPERATIONS
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEOLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
OPTAIN HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTINA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHELCOM TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VERILY LIFE SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZILIA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3 3
Misfocusing 2 2
Circuit Failure 1 1
Fire 1 1
Device Fell 1 1
Power Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6

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