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 a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-09-13 under approval 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. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K232158.
When was GenX-CR approved by the FDA?
GenX-CR received FDA 510(k) clearance on 2023-09-13, under approval number K232158.
What company makes GenX-CR?
GenX-CR is manufactured by Genoray Co., Ltd..
What is the FDA product code for GenX-CR?
The FDA product code for GenX-CR is MUH.
Other Devices by Genoray Co., Ltd.
Related Devices (Code: MUH)
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.