Radiology AI Directory

Vendor

Orca Dental AI, Ltd.

2 FDA-cleared listings in this directory.

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FDA-cleared K252538

CEPHX3D

Orca Dental AI, Ltd.

CEPHX3D processes dental and craniomaxillofacial images to support diagnosis and treatment planning, including three-dimensional models, viewing, segmentation, measurements, and...

Modality
CBCT
Anatomy
Dental and craniomaxillofacial anatomy
Decision
2026-03-05
Quantification and segmentation
FDA-cleared K231396

CEPHX- Cephalometric Analysis Software

Orca Dental AI LTD

Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.

Modality
X-ray/Radiography
Anatomy
Head/Neck
Decision
2024-01-31
X-ray/Radiography workflow