FDA Product Code SAO: Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
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.
Leading manufacturers include 16 Bit, Inc. and Naitive Technologies, Ltd..
FDA 510(k) Cleared Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density Devices (Product Code SAO)
About Product Code SAO - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SAO since 2024, with 1 receiving FDA clearance (average review time: 246 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under SAO have taken an average of 119 days to reach a decision - down from 372 days historically, suggesting improved FDA processing for this classification.
SAO devices are reviewed by the Radiology panel. Browse all Radiology devices →