IMAGEnet6 Ophthalmic Data System
K-Number: K232828 · 2024-03-01
ApplicantTopcon Corporation
Decision Date2024-03-01
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
IMAGEnet6 Ophthalmic Data System is a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2024-03-01 under approval number K232828. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IMAGEnet6 Ophthalmic Data System?
IMAGEnet6 Ophthalmic Data System is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Topcon Corporation. The 510(k) number is K232828.
When was IMAGEnet6 Ophthalmic Data System approved by the FDA?
IMAGEnet6 Ophthalmic Data System received FDA 510(k) clearance on 2024-03-01, under approval number K232828.
What company makes IMAGEnet6 Ophthalmic Data System?
IMAGEnet6 Ophthalmic Data System is manufactured by Topcon Corporation.
What is the FDA product code for IMAGEnet6 Ophthalmic Data System?
The FDA product code for IMAGEnet6 Ophthalmic Data System is NFJ.
Other Devices by Topcon Corporation
Related Devices (Code: NFJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.