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SQuEEZ Software

by Cardiowise, Inc.

510(k) K201250

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201250 Date18 Dec 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

SQuEEZ Software is a medical imaging software device used with cardiac computed tomography studies. It is designed to assist cardiologists and radiologists in assessing heart function during cardiac evaluation by applying machine learning technology to image processing to create transparent, unbiased clinical evaluation.

The software is supplied as a non-sterile, reusable software product intended for use in clinical settings such as hospitals and imaging centers. It does not require sterilization and is not implanted or invasive. Regulatory authorization is based on FDA 510(k) clearance (K201250) under product code LLZ, with a determination of substantial equivalence to a predicate device.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is SQuEEZ Software used for?

    SQuEEZ Software is used to assist cardiologists and radiologists in assessing heart function during cardiac computed tomography studies by applying machine learning technology to image processing for transparent, unbiased clinical evaluation.

  • How is SQuEEZ Software supplied and is it sterile?

    SQuEEZ Software is supplied as a non-sterile, reusable software product intended for use in clinical settings such as hospitals and imaging centers; it does not require sterilization because it is not implanted, invasive, or in contact with the patient.

  • What regulatory authorization does SQuEEZ Software have?

    SQuEEZ Software has FDA 510(k) clearance (K201250) under product code LLZ, with a determination of substantial equivalence to a predicate device based on traditional review.