VELMENI for DENTISTS (V4D) 3D

Q: What is the product code of K254096?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.

FDA 510(k) K254096 · Velmeni, Inc.

Substantially Equivalent

510(k) numberK254096

Submission

Device name: VELMENI for DENTISTS (V4D) 3D
Applicant: Velmeni, Inc.
Sunnyvale, CA, US
Received: December 19, 2025
Decision date: July 23, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QIH – Automated Radiological Image Processing Software
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2050
Specialty: Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other 510(k)s with product code QIH

510(k)	Device	Applicant	Decision
K261795	Quicktome Software SuiteQIH · Traditional	Omniscient Neurotechnology Pty, Ltd.	09/10/2026SE
K260879	4DMQIH · Traditional	Invia, LLC	09/10/2026SE
K251417	ReVISION 2QIH · Traditional	Argus Cognitive, Inc.	09/09/2026SE
K260525	NextMR SpineQIH · Traditional	MRI2CT, Inc.	09/04/2026SE
K260811	Heartvue.ProtonQIH · Traditional	Heartvue.ai, Inc.	08/26/2026SE
K261595	Ceevra Reveal 4QIH · Traditional	Ceevra, Inc.	08/25/2026SE
K262127	DS Core CBCT AnatomyQIH · Traditional	Dentsply Sirona	08/21/2026SE
K260584	BoneMRIQIH · Traditional	Mriguidance B.V.	08/21/2026SE
K261641	Lower Limb AI (LLAI)QIH · Traditional	AI Planning Logic, Inc.	08/18/2026SE
K253794	Prostate CoreQIH · Traditional	Lucida Medical, Ltd.	08/10/2026SE

More from Lucida Medical, Ltd.

510(k)	Device	Decision
K252953	Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional	05/11/2026SE
K250753	VELMENI for DENTISTS (V4D)MYN · Traditional	09/02/2025SE
K240003	Velmeni for Dentists (V4D)MYN · Traditional	08/30/2024SE

Questions and answers

When was VELMENI for DENTISTS (V4D) 3D cleared by the FDA?

VELMENI for DENTISTS (V4D) 3D (K254096) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 216 days after the submission was received.

What is the product code of K254096?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.