Not Cleared Direct

DEN230023 - Rho (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230023 · 16 Bit, Inc. · Radiology device
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Apr 2024
Decision
372d
Days
Class 2
Risk

DEN230023 is an FDA 510(k) submission (not cleared) for the Rho. Classified as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density (product code SAO), Class II - Special Controls.

Submitted by 16 Bit, Inc. (Ancaster, CA). The FDA issued a Not Cleared (DENG) decision on April 9, 2024 after a review of 372 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1171 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 372 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all 16 Bit, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 107d · This submission: 372d
Pathway characteristics

Device Classification

Product Code SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.