medXion NEXUS— 510(k) K253935
Substantially EquivalentmedXion Technologies, Inc.
FDA 510(k) clearance K253935 for medXion NEXUS, Substantially Equivalent on 2026-05-15. Applicant: medXion Technologies, Inc.. Device class: 2.
Summary
medXion Technologies' medXion NEXUS is filed under OAS, dental computed tomography x-ray systems.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
medXion filed from Tokyo, Japan. The decision came 157 calendar days after receipt (December 9, 2025 to May 15, 2026).
Clearance details
- Applicant
- medXion Technologies, Inc.
- 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
- Tokyo, JP
Recent devices under product code OAS
view allData sourced from openFDA. This site is unofficial and independent of the FDA.