myray ProXIma X6— 510(k) K252353
Substantially EquivalentCefla S.C.
FDA 510(k) clearance K252353 for myray ProXIma X6, Substantially Equivalent on 2026-03-10. Applicant: Cefla S.C.. Device class: 2.
Summary
Cefla's myray ProXIma X6 is filed under OAS, dental computed tomography x-ray systems. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Cefla filed from Imola (Bo), Italy. The decision came 224 calendar days after receipt (July 29, 2025 to March 10, 2026).
Clearance details
- Applicant
- Cefla S.C.
- Product code
- Product 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.