eXaSkin Plus— 510(k) K252784
Substantially EquivalentAnatomical Geometry S.L.
FDA 510(k) clearance K252784 for eXaSkin Plus, Substantially Equivalent on 2026-05-22. Applicant: Anatomical Geometry S.L.. Device class: 2.
Summary
Anatomical Geometry filed eXaSkin Plus under MUJ, radiation therapy treatment planning systems. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
The company is in Mairena Del Aljarafe, Spain. Review took 262 calendar days (September 2, 2025 to May 22, 2026).
Clearance details
- Applicant
- Anatomical Geometry S.L.
- Product code
- Product code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mairena Del Aljarafe, ES
Recent devices under product code MUJ
view allData sourced from openFDA. This site is unofficial and independent of the FDA.