DeviceClearance

Product code SAO— Radiology

DeepXray Spina

Classification name
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Device class
Class 2
Regulation
21 CFR 892.1171
Advisory panel
Radiology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SAO under 21 CFR 892.1171, via openFDA

Market context for product code SAO

FDA has cleared 3 devices under product code SAO between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SAO

Recent clearances under product code SAO

Data sourced from openFDA. This site is unofficial and independent of the FDA.