myray ProXIma X6
K-Number: K252353 · 2026-03-10
ApplicantCefla S.C.
Decision Date2026-03-10
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
myray ProXIma X6 is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2026-03-10 under approval number K252353. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the myray ProXIma X6?
myray ProXIma X6 is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by Cefla S.C.. The 510(k) number is K252353.
When was myray ProXIma X6 approved by the FDA?
myray ProXIma X6 received FDA 510(k) clearance on 2026-03-10, under approval number K252353.
What company makes myray ProXIma X6?
myray ProXIma X6 is manufactured by Cefla S.C..
What is the FDA product code for myray ProXIma X6?
The FDA product code for myray ProXIma X6 is OAS.
Other Devices by Cefla S.C.
Related Devices (Code: OAS)
K161900HYPERION X5Cefla S.C.
K160166X-MIND triumDe Gotzen S.R.L.
K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
K161881PreXion3D ExcelsiorPrexion Corporation
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.