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FDA 510(k)

Ophthalmic Software Platform RX

K-Number: K173689 · 2018-02-23

ApplicantCanon Inc. -Medical Equipment Group
Decision Date2018-02-23
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ophthalmic Software Platform RX is a medical device manufactured by Canon Inc. -Medical Equipment Group. It received FDA 510(k) clearance on 2018-02-23 under approval number K173689. 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 Ophthalmic Software Platform RX?

Ophthalmic Software Platform RX is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by Canon Inc. -Medical Equipment Group. The 510(k) number is K173689.

When was Ophthalmic Software Platform RX approved by the FDA?

Ophthalmic Software Platform RX received FDA 510(k) clearance on 2018-02-23, under approval number K173689.

What company makes Ophthalmic Software Platform RX?

Ophthalmic Software Platform RX is manufactured by Canon Inc. -Medical Equipment Group.

What is the FDA product code for Ophthalmic Software Platform RX?

The FDA product code for Ophthalmic Software Platform RX is NFJ.

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Related PubMed Literature

PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026)

Related Devices (Code: NFJ)

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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.

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