DEN230023 is an FDA 510(k) submission for the Rho. This device is classified as a Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density (Class II - Special Controls, product code SAO).
Submitted by 16 Bit, Inc. (Ancaster, CA). The FDA issued a Not Cleared (DENG) decision on April 9, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1171. 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) Number | DEN230023 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 03, 2023 |
| Decision Date | April 09, 2024 |
| Days to Decision | 372 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | SAO - Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1171 |
| 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. |