Rho is an AI-enabled medical device from 16 Bit Inc that the U.S. FDA granted through De Novo DEN230023 on April 9, 2024. Its lead review panel is Radiology and its primary product code is SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density).
See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.
Key facts
| Submission number | DEN230023 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | 16 Bit Inc |
| Lead review panel | Radiology |
| Primary product code | SAO — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Applicant (openFDA) | 16 Bit, Inc. |
| Applicant location | Ancaster, CA |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1171 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Rho went through this pathway (DEN230023).
openFDA lists it as a Class 2 device under 21 CFR 892.1171. Class II devices are moderate risk and are subject to general and special controls.
Product code SAO covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. 16 Bit Inc has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.