Not Cleared Direct

DEN190040 - Caption Guidance (FDA 510(k) Clearance)

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

DEN190040 · Bay Labs, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
164d
Days
Class 2
Risk

DEN190040 is an FDA 510(k) submission (not cleared) for the Caption Guidance. Classified as Image Acquisition And/or Optimization Guided By Artificial Intelligence (product code QJU), Class II - Special Controls.

Submitted by Bay Labs, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on February 7, 2020 after a review of 164 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Radiology review framework.

View all Bay Labs, Inc. devices

Submission Details

510(k) Number DEN190040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 27, 2019
Decision Date February 07, 2020
Days to Decision 164 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics

Device Classification

Product Code QJU Image Acquisition And/or Optimization Guided By Artificial Intelligence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2100
Definition A Radiological Acquisition And/or Optimization Guidance System Is A Device That Is Intended To Aid In The Acquisition And/or Optimization Of Images And/or Diagnostic Signals. The Device Interfaces With The Acquisition System, Analyzes Its Output, And Provides Guidance And/or Feedback To The Operator For Improving Image And/or Signal Quality.
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.