510(k) DEN230023
- Device
- Rho
- Applicant
- 16 Bit, Inc.
- 510(k) number
- DEN230023
- Product code
- SAO
- Decision
- Unknown (DENG)
- Decision date
- 2024-04-09
- Date received
- 2023-04-03
- Regulation
- 892.1171
- Classification name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Dr. Catriona Syme
- Address
- 76 Parker Ave. Ancaster CA L9G1A7 L9G1A7
FDA Registration Numbers#
- 3041277558
- 3033583855
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SAO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251408 | OsteoSight™ Hip (v1) | Naitive Technologies, Ltd. | 2025-09-02 |