Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

SAO · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1171

Classification

FDA Product Code: SAO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.1171
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown