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510(k) K200621

Caption Interpretation Automated Ejection Fraction Software by Caption Health — Product Code QIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2020
Date Received
March 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Radiological Image Processing Software
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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.

Other clearances by Caption Health

  • K243065 — Cardiac Guidance (January 15, 2025)
  • DEN220063 — Caption Interpretation Automated Ejection Fraction Software (February 24, 2023)
  • K210747 — Caption Interpretation Automated Ejection Fraction Software (January 19, 2022)
  • K201992 — Caption Guidance (September 18, 2020)
  • K200755 — Caption Guidance (April 16, 2020)

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  • K253535 — Ligence Heart (February 27, 2026)
  • K260217 — AI Platform 2.2 (AIP002) (February 24, 2026)
  • K252084 — AI4CMR v2.0 (February 11, 2026)
  • K254016 — MI View&GO (February 10, 2026)
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  • K252496 — Neurophet AQUA AD Plus (January 29, 2026)
  • K253735 — AV Vascular (January 22, 2026)