myray ProXIma X6— 510(k) K252353

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K252353 for myray ProXIma X6, Substantially Equivalent on 2026-03-10. Applicant: Cefla S.C.. Device class: 2.

Clearance details

Applicant
Cefla S.C.
Product code
Code OAS
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Imola (Bo), IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code OAS

view all

More clearances from Cefla S.C.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.