Not Cleared Direct

DEN220063 - Caption Interpretation Automated Ejection Fraction Software (FDA 510(k) Clearance)

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

DEN220063 · Caption Health, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
149d
Days
Class 2
Risk

DEN220063 is an FDA 510(k) submission (not cleared) for the Caption Interpretation Automated Ejection Fraction Software. Classified as Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan (product code QVD), Class II - Special Controls.

Submitted by Caption Health, Inc. (Brisbane, US). The FDA issued a Not Cleared (DENG) decision on February 24, 2023 after a review of 149 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2055 - 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 Caption Health, Inc. devices

Submission Details

510(k) Number DEN220063 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 28, 2022
Decision Date February 24, 2023
Days to Decision 149 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 107d · This submission: 149d
Pathway characteristics

Device Classification

Product Code QVD Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2055
Definition A Radiological Machine Learning Quantitative Imaging Software With Predetermined Change Control Plan Is A Software-only Device Which Employs Machine Learning Algorithms On Radiological Images To Provide Quantitative Imaging Outputs. The Device Includes Functions To Support Outputs Such As View Selection, Segmentation And Landmarking. The Design Specifications Include Planned Modifications That May Be Made To The Device Consistent With An Established Predetermined Change Control Plan.
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.