FDA-cleared K250755

DS Core Diagnosis

Dentsply Sirona Inc.

Displays and supports interpretation of digital/digitized dental media, including CBCT and other 2D/3D X-ray images; its Panoramic Curve Proposal generates a proposed dental-arch...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2025-08-12
FDA-cleared K243989

Second OpinionĀ® 3D

Pearl, Inc.

Second Opinion 3D processes dental CBCT radiographs to identify and mark dentition, maxilla, mandible, inferior alveolar canal and mental foramen, maxillary sinus, nasal space,...

Modality
CBCT
Anatomy
Dental and craniomaxillofacial anatomy
Decision
2025-05-23
FDA-cleared K233925

Relu Creator

Relu BV

Relu Creator manages, transfers, displays, enhances, and analyzes dental and craniomaxillofacial image information and provides design input for dental solutions within the...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2024-06-13
FDA-cleared K223490

FlightPlan for Embolization

GE Medical Systems SCS

Post-processes 3D X-ray angiography to help physicians visualize vasculature during embolization planning.

Modality
CBCT
Anatomy
Vasculature throughout the body
Decision
2023-03-21