510(k) K253192
K253192 is an FDA 510(k) premarket notification submitted by Alpha Intelligence Manifolds, Inc. for the device "DeepXray Spina". The FDA issued a decision of Substantially Equivalent on Jun 10, 2026. The device falls under product code SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density), a Class II device regulated under 21 CFR 892.1171. Alpha Intelligence Manifolds, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 2026
- Date Received
- Sep 26, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Device Class
- Class II
- Regulation Number
- 892.1171
- Review Panel
- RA
- Submission Type
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.