IMAGEnet 6 Ophthalmic Data System
K-Number: K171370 · 2017-11-01
ApplicantTopcon Corporation
Decision Date2017-11-01
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
IMAGEnet 6 Ophthalmic Data System is a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2017-11-01 under approval number K171370. 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 IMAGEnet 6 Ophthalmic Data System?
IMAGEnet 6 Ophthalmic Data System is a medical device that received FDA 510(k) clearance on 2017-11-01. It is manufactured by Topcon Corporation. The 510(k) number is K171370.
When was IMAGEnet 6 Ophthalmic Data System approved by the FDA?
IMAGEnet 6 Ophthalmic Data System received FDA 510(k) clearance on 2017-11-01, under approval number K171370.
What company makes IMAGEnet 6 Ophthalmic Data System?
IMAGEnet 6 Ophthalmic Data System is manufactured by Topcon Corporation.
What is the FDA product code for IMAGEnet 6 Ophthalmic Data System?
The FDA product code for IMAGEnet 6 Ophthalmic Data System is NFJ.
Related PubMed Literature
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.