FDA product code SAO: Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
SAO is the FDA product code for radiology software for opportunistic evaluation of low bone mineral density. It is a Class II device, regulated under 21 CFR 892.1171 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under SAO, 2 in the last five years, from 2 different applicants. The average 510(k) review took 188 days (median 188); 188 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Device class | Class II |
| Regulation | 21 CFR 892.1171 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for SAO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 119 |
| 2026 | 1 | 257 |
Compare with all 510(k) review times · Search every SAO clearance
Top SAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alpha Intelligence Manifolds, Inc. | 1 | 2026-06-10 |
| Naitive Technologies, Ltd. | 1 | 2025-09-02 |
Most recent SAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253192 | Alpha Intelligence Manifolds, Inc. | DeepXray Spina | 2026-06-10 | 257 |
| K251408 | Naitive Technologies, Ltd. | OsteoSight Hip (v1) | 2025-09-02 | 119 |
Recalls for SAO devices
openFDA lists no recalls for product code SAO.
Frequently asked questions
What is FDA product code SAO?
SAO is the FDA product code for radiology software for opportunistic evaluation of low bone mineral density. It is a Class II device, regulated under 21 CFR 892.1171 and reviewed by the Radiology panel.
What device class is SAO?
Class II, regulation 21 CFR 892.1171. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAO?
Across 2 cleared submissions the average was 188 days from receipt to decision (median 188).
Which companies have the most SAO clearances?
Alpha Intelligence Manifolds, Inc. (1); Naitive Technologies, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAO
- Run a recall and safety report across every SAO manufacturer
- Watch product code SAO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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