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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
Product CodeHKI
Regulation Number 886.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
CANON INC.
  SUBSTANTIALLY EQUIVALENT 2
CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALVUE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HUVITZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOWA COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUNEAU TECHNOLOGY OPERATIONS
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEOLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OPTINA DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
OPTINA DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTOMED OYJ
  SUBSTANTIALLY EQUIVALENT 1
PHELCOM TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASOPTIC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZILIA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 3 3
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 5 5
Misfocusing 2 2
Loss of Data 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Power Problem 1 1
Data Problem 1 1
Device Fell 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Bradycardia 1 1
Fatigue 1 1
Electric Shock 1 1
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merge Healthcare, Inc. II Feb-25-2019
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