meddevicedb.com FDA Device Reference

Rho

DEN230023 Class II Direct
Decision Date
2024-04-09
Sponsor / Applicant
16 Bit, Inc.

Technical Specification

510(k) Submission ID DEN230023
Product Code SAO
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1171
Decision Date 2024-04-09
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Rho received FDA 510(k) clearance under submission number DEN230023, sponsored by 16 Bit, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-04-09.

Classification & Regulation

This clearance is catalogued under FDA product code SAO and 21 CFR 892.1171, within the Radiology review panel as a Class II device.