Nobel Biocare AB radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K231898

DTX Studio Clinic (4.0)

Nobel Biocare AB

Authorized purpose: Acquire, manage, transfer, analyze, display, enhance, store, and communicate dental and craniomaxillofacial image information for diagnosis and treatment planning, restorative design input, and guided implant-surgery support; its CADe function identifies and localizes specified dental findings during concurrent dentist review of bitewing and periapical radiographs of permanent teeth in patients aged 15 years and older.

Modality: X-ray/Radiography
Anatomy: Dental and craniomaxillofacial regions; permanent teeth
Decision: 2023-12-08

Detection and CADe

FDA-cleared K221921

DTX Studio Clinic 3.0

Nobel Biocare AB

Authorized purpose: DTX Studio Clinic 3.0 analyzes intraoral bitewing and periapical radiographs of permanent teeth in patients aged 15 years and older to identify and localize caries, calculus, periapical radiolucency, root-canal filling deficiency, margin discrepancy, and bone loss for concurrent dentist review.

Modality: X-ray/Radiography
Anatomy: Permanent teeth; intraoral dental findings
Decision: 2023-03-28

MSK and bone