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TPLC
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Device
camera, ophthalmic, ac-powered
Product Code
HKI
Regulation Number
886.1120
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Circuit Failure
1
1
Data Problem
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Power Problem
1
1
Connection Problem
1
1
Device Fell
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Electrical /Electronic Property Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
Electric Shock
1
1
Fatigue
1
1
Not Applicable
1
1
No Known Impact Or Consequence To Patient
1
1
Bradycardia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Merge Healthcare, Inc.
II
Feb-25-2019
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