Cleared Traditional

Caption Interpretation Automated Ejection Fraction Software (K200621) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200621 · Caption Health · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
135d
Days
Class 2
Risk

K200621 is an FDA 510(k) clearance for the Caption Interpretation Automated Ejection Fraction Software. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Caption Health (Brisbane, US). The FDA issued a Cleared decision on July 22, 2020 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Caption Health devices

Submission Details

510(k) Number K200621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2020
Decision Date July 22, 2020
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 107d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 297
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K200621.
WRDensity by Whiterabbit.ai
K202013 · Whiterabbit.Ai, Inc. · Oct 2020
LVivo Seamless
K202546 · Dia Imaging Analysis, Ltd. · Sep 2020
AI-Rad Companion Prostate MR
K193283 · Siemens Medical Solutions USA, Inc. · Jul 2020
Ezra Plexo Software
K192969 · Ezra Ai, Inc. · Jul 2020
LVivo Software Application
K200232 · Dia Imaging Analysis, Ltd. · Jun 2020
MEDO ARIA
K200356 · Medo.Ai · Jun 2020