Device class
Class II
Regulation 892.1171
Total clearances
3
2024-04-09 → 2026-06-10
Definition
What is 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.
Classification details
Medical specialty
Radiology
Regulation number
892.1171
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Naitive Technologies, Ltd. |
1 |
1 |
2025-09-02 |
|
16 Bit, Inc. |
1 |
0 |
2024-04-09 |
|
Alpha Intelligence Manifolds, Inc. |
1 |
1 |
2026-06-10 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 77086 |
CPT
|
— |
High
|
CPT for bone density (BMD) measurement and interpretation, standard for bone mineral density assessment |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-10 |
K253192 |
Alpha Intelligence Manifolds, Inc.
|
DeepXray Spina |
| 2025-09-02 |
K251408 |
Naitive Technologies, Ltd.
|
OsteoSight Hip (v1) |
| 2024-04-09 |
DEN230023 |
16 Bit, Inc.
|
Rho |