Rho Radiology Software
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by 16 Bit, Inc.
Identifiers
- 510(k) Number
- DEN230023 FDA 510(k)
- FDA Product Code
- SAO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1171 FDA 510(k)
- Regulation Number
- 892.1171 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
Rho is a Radiology Software for Opportunistic Evaluation of Low Bone Mineral Density, designed to assist in the detection of low bone mineral density using artificial intelligence. It estimates lumbar and femoral bone mineral density and T-scores from standard single-energy X-rays of the lumbar spine, thoracic spine, chest, pelvis, hip, knee, or hand. The software operates as a computer-aided detection tool to flag potential cases for further clinical review.
The device is supplied as a software application and is intended for use in radiology settings, where it integrates with existing imaging workflows. It is not classified as single-use or reusable but is instead a reusable software solution. No specific sterility or MRI safety information is provided, and the device is available in a single configuration (no size variations). Authorisations include FDA 510K clearance and MDR compliance, with regulatory classification under device class 2 (OpenFDA: 892.1171).
Frequently asked questions
What types of X-ray images can Rho analyze to estimate bone mineral density and T-scores?
Rho is designed to analyze standard single-energy X-rays of the lumbar spine, thoracic spine, chest, pelvis, hip, knee, or hand. It uses artificial intelligence to estimate lumbar and femoral bone mineral density and T-scores from these images, helping radiologists identify potential cases of low bone mineral density for further clinical review.
How does Rho integrate into existing radiology workflows, and is it meant for single-use or reusable settings?
Rho functions as a software application that integrates with current radiology workflows, allowing seamless use alongside existing imaging systems. Unlike physical devices, it is a reusable software solution—there are no consumable components or single-use constraints, and it does not require sterilization or MRI safety considerations.
What regulatory approvals does Rho hold, and how does it classify under medical device regulations?
Rho holds FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). It is classified as a Class 2 device under OpenFDA’s regulatory framework (product code SAO, classification 892.1171), indicating it is intended for opportunistic evaluation of low bone mineral density in radiology settings.
Does Rho come in different sizes or configurations, or is it available as a single version?
Rho is supplied as a single, unified software application with no size variations or alternative configurations. It operates uniformly across all compatible imaging systems, providing consistent functionality for detecting potential low bone mineral density cases.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rho – Wikipedia, 16 Bit - Rho, Rho - Wikipedia, 16 BIT | Home, Rho Symbol (ρ)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN230023 | Class II | Active |
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Manufacturer
- Manufacturer
- 16 Bit, Inc.
Sources (2)
- FDA 510(k) DEN230023 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026