Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Radiology software for opportunistic evaluation of low bone mineral density is a software device that analyzes radiological images acquired for other clinical purposes, applying an algorithm to estimate bone mineral density (BMD) to assist healthcare professionals in deciding whether to further evaluate patients for possible low BMD within a bone health screening program. It is classified as FDA Class II (510(k) required) under regulation 892.1171 in the Radiology specialty, with product code SAO. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAO
- Device Class
- FDA class 2
- Regulation Number
- 892.1171
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.