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FDA 510(k)

CANON Fundus Camera CR-10 (CR-10)

K-Number: K241049 · 2024-05-15

ApplicantCanon, Inc.
Decision Date2024-05-15
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CANON Fundus Camera CR-10 (CR-10) is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2024-05-15 under approval number K241049. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANON Fundus Camera CR-10 (CR-10)?

CANON Fundus Camera CR-10 (CR-10) is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Canon, Inc.. The 510(k) number is K241049.

When was CANON Fundus Camera CR-10 (CR-10) approved by the FDA?

CANON Fundus Camera CR-10 (CR-10) received FDA 510(k) clearance on 2024-05-15, under approval number K241049.

What company makes CANON Fundus Camera CR-10 (CR-10)?

CANON Fundus Camera CR-10 (CR-10) is manufactured by Canon, Inc..

What is the FDA product code for CANON Fundus Camera CR-10 (CR-10)?

The FDA product code for CANON Fundus Camera CR-10 (CR-10) is HKI.

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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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