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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, image management, ophthalmic
Regulation Description Medical image management and processing system.
Product CodeNFJ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTRIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, AG
  SUBSTANTIALLY EQUIVALENT 3
CENTERVUE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HUVITZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED OPHTHALMIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOWA CO. LTD. CHOFU
  SUBSTANTIALLY EQUIVALENT 1
MERIT CRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPHTHALMIC LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RETINAI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOPCON HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
TOPCON HEALTHCARE SOLUTIONS EMEA OY
  SUBSTANTIALLY EQUIVALENT 1
TOPCON HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISIONQUEST BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 2 2
Output Problem 1 1
Program or Algorithm Execution Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Data Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Blurred Vision 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diagnos Inc II Mar-25-2022
2 Kowa Optimed Inc II Dec-17-2020
3 MedicalCommunications GmbH II Sep-30-2025
4 Topcon Medical Systems, Inc. II Nov-12-2024
5 Topcon Medical Systems, Inc. II Feb-04-2021
6 Topcon Medical Systems, Inc. II Apr-12-2019
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