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NFJ — System, Image Management, Ophthalmic Class II

FDA Device Classification

Classification Details

Product Code
NFJ
Device Class
Class II
Regulation Number
892.2050
Submission Type
Review Panel
OP
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K234076centervueiCare ALTIUS CWAugust 22, 2024
K232828topcon corporationIMAGEnet6 Ophthalmic Data SystemMarch 1, 2024
K232944carl zeiss meditecCALLISTO eyeDecember 21, 2023
K232555topcon healthcare solutionsHarmonyNovember 20, 2023
K231676carl zeiss meditecCALLISTO eyeAugust 28, 2023
K232088altrisAltris IMSJuly 31, 2023
K220929merit croExcelsiorOctober 31, 2022
K213527carl zeiss meditecFORUMAugust 15, 2022
K211715retinai medicalRetinAI DiscoveryApril 28, 2022
K210396topcon healthcare solutions emeaHarmony Referral SystemSeptember 13, 2021
K203244konan medicalCellChek 20 rcJune 15, 2021
K200422visionquest biomedicalImage Quality Analyzer (IQA)December 24, 2020
K201273canonImageSPECTRUMSeptember 25, 2020
K200954topcon healthcare solutionsGlaucoma ModuleAugust 3, 2020
K200385integrated ophthalmic systemsCONTINUUM PACSMarch 16, 2020
K200275ophthalmic labsOVision Imaging SystemMarch 3, 2020
K191615huvitz coHuvitz Imaging SystemJuly 18, 2019
K190056kowa co. ltd. chofuKOWA VK-2sFebruary 12, 2019
K181501neurovision imagingAfinaNovember 2, 2018
K182318carl zeiss meditecRetina WorkplaceOctober 24, 2018