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510(k) K232828

Device
IMAGEnet6 Ophthalmic Data System
Applicant
Topcon Corporation
510(k) number
K232828
Product code
NFJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-01
Date received
2023-09-13
Regulation
892.2050
Classification name
System, Image Management, Ophthalmic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ryota Kitawaki
Address
75-1 Hasunuma-Cho Itabashi-Ku JP 174-8580 174-8580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NFJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K234076iCare ALTIUS CWCentervue S.P.A.2024-08-22
K232944CALLISTO eyeCarl Zeiss Meditec, AG2023-12-21
K232555HarmonyTopcon Healthcare Solutions2023-11-20
K231676CALLISTO eyeCarl Zeiss Meditec, AG2023-08-28
K232088Altris IMSAltris, Inc.2023-07-31
K220929ExcelsiorMerit Cro, Inc.2022-10-31
K213527FORUMCarl Zeiss Meditec, AG2022-08-15
K211715RetinAI DiscoveryRetinai Medical AG2022-04-28
K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy2021-09-13
K203244CellChek 20 rcKonan Medical, Inc.2021-06-15
K200422Image Quality Analyzer (IQA)Visionquest Biomedical, Inc.2020-12-24
K201273ImageSPECTRUMCanon, Inc.2020-09-25
K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.2020-08-03
K200385CONTINUUM PACSIntegrated Ophthalmic Systems, Inc.2020-03-16
K200275OVision Imaging SystemOphthalmic Labs, Inc.2020-03-03