VELMENI for DENTISTS (V4D) 3D— 510(k) K254096
Substantially EquivalentVelmeni, Inc.
FDA 510(k) clearance K254096 for VELMENI for DENTISTS (V4D) 3D, Substantially Equivalent on 2026-07-23. Applicant: Velmeni, Inc.. Device class: 2.
Summary
VELMENI for DENTISTS (V4D) 3D from Velmeni is filed under QIH, automated radiological image processing software. The record doesn't describe what the software processes or outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Velmeni filed from Sunnyvale, California. Review took 216 calendar days (December 19, 2025 to July 23, 2026).
Clearance details
- Applicant
- Velmeni, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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