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FDA 510(k)

GenX-CR

K-Number: K232158 · 2023-09-13

ApplicantGenoray Co., Ltd.
Decision Date2023-09-13
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GenX-CR is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K232158. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GenX-CR?

GenX-CR is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K232158.

When did GenX-CR receive FDA 510(k) clearance?

GenX-CR received FDA 510(k) clearance on 2023-09-13, under 510(k) number K232158.

Who is the listed applicant for GenX-CR?

The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenX-CR?

The FDA product code for GenX-CR is MUH.

Other records listing Genoray Co., Ltd. as applicant

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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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