Velmeni, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K252953

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Authorized purpose: Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.

Modality: X-ray/Radiography
Anatomy: Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
Decision: 2026-05-11

MSK and bone Detection and CADe

FDA-cleared K250753

VELMENI for DENTISTS (V4D)

Velmeni Inc.

Authorized purpose: Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients aged 15 years and older; final diagnoses and treatment plans remain the dentist's responsibility.

Modality: X-ray/Radiography
Anatomy: Dental/Maxillofacial
Decision: 2025-09-02

Detection and CADe

FDA-cleared K240003

Velmeni for Dentists (V4D)

Velmeni Inc.

Authorized purpose: VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. It provides additional information for dentists and is not a replacement for complete examination or clinical judgment; final diagnoses and treatment plans are the dentist's responsibility.

Modality: X-ray/Radiography
Anatomy: Permanent teeth; digital bitewing, periapical, and panoramic dental radiographs
Decision: 2024-08-30

Detection and CADe