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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 the device name listed in this FDA 510(k) record. The listed applicant is Canon Inc. -Medical Equipment Group. It received FDA 510(k) clearance on 2018-02-23 under 510(k) 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. The listed applicant is Canon Inc. -Medical Equipment Group. The 510(k) number is K173689.

When did Ophthalmic Software Platform RX receive FDA 510(k) clearance?

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

Who is the listed applicant for Ophthalmic Software Platform RX?

The FDA 510(k) record lists Canon Inc. -Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Canon Inc. -Medical Equipment Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NFJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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