3 devices · 3 companies · 2024 to 2026
Product code SAO: Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
3 devices under product code SAO, 2024 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density. 21 CFR 892.1171, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| DeepXray SpinaK253192 · 510(k) | Alpha Intelligence Manifolds, Inc. | Radiology | database entry | |
| OsteoSight HipK251408 · 510(k) | Naitive Technologies Ltd | Radiology | database entry | |
| RhoDEN230023 · De Novo | 16 Bit Inc | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.