21 CFR 892.1171 — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1171
Identification
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 Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SAO | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | 2 | 2 | AI/ML, SaMD |
Special Controls
SAO — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
In combination with the general controls of the FD&C Act, radiology software for opportunistic evaluation of low bone mineral density is subject to the following special controls:
De Novo Order DEN230023
