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FDA-cleared K250023

SMART PCFD

Disior Ltd

Authorized purpose: SMART PCFD uses algorithms to support orthopedic diagnosis and surgical planning for progressive collapsing foot deformity from weight-bearing CT, including three-dimensional models, measurements, fixation devices, and osteotomy planning.

Modality
CT/CTA
Anatomy
Foot and ankle
Decision
2025-09-29
FDA-cleared K240736

SMART Bun-Yo-Matic X-Ray

Disior Ltd

Foot and ankle radiograph analysis for orthopaedic visualization, measurements, and preoperative surgical planning by qualified professionals.

Modality
X-ray/Radiography
Anatomy
Foot/Ankle
Decision
2024-07-02
FDA-cleared K240642

SMART Bun-Yo-Matic CT

Disior Ltd

Authorized purpose: Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.

Modality
CT/CTA
Anatomy
Foot/Ankle
Decision
2024-06-20
FDA-cleared K223757

Bonelogic

Disior Ltd

Authorized purpose: Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and ankle 3D models and measurements for clinician review.

Modality
CT/CTA
Anatomy
Foot/ankle
Decision
2023-12-08