FDA-cleared K251002

Videa Dental AI

VideaHealth Inc.

Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-19
FDA-cleared K232384

Videa Dental Assist

VideaHealth, Inc.

Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (suspected findings, historical treatments, and normal anatomy)
Decision
2023-12-15
FDA-cleared K223296

Videa Perio Assist

VideaHealth, Inc.

Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2023-02-06
FDA-cleared K213795

Videa Caries Assist

VideaHealth, Inc

Concurrent-read CADe to identify and localize carious lesions on bitewing radiographs from adults at least 22 years old for board-licensed dentists; the device is an aid and does...

Modality
X-ray/Radiography
Anatomy
Teeth and tooth surfaces, including proximal, buccal/lingual, occlusal, root, and cervical surfaces
Decision
2022-04-21