DEN230023
- 510(k) number
- DEN230023
- Device name
- Rho
- Applicant
- 16 Bit, Inc. CA
- Product code
- SAO — Radiology Software For Opportunistic Evaluation Of L
- Decision date
- 2024-04-09
- Date received
- 2023-04-03
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Radiology
Official FDA record: DEN230023
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.