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Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers

by Syntermed, Inc. 510(k)

Active United States

510(k) K014033

Overview

Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers is a software system used for cardiac imaging analysis. It is substantially equivalent to a predicate device and falls under the radiology medical specialty.

The device received FDA 510(k) clearance under K014033 with a traditional clearance type and regulation number 892.1200. It is classified as a Class II medical device and is intended for use in nuclear cardiology for the analysis of SPECT and PET myocardial perfusion studies, including calcium scoring.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK014033 Date22 Feb 2002ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Syntermed, Inc.

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Questions

  • What is the Emory Cardiac Toolbox 2.1 used for?

    It is used for cardiac imaging analysis, specifically for the analysis of SPECT and PET myocardial perfusion studies, including calcium scoring, in nuclear cardiology.

  • How is the Emory Cardiac Toolbox 2.1 supplied or deployed?

    It is a software system designed to execute on nuclear medicine computers, meaning it is installed and run on compatible hardware used in nuclear medicine departments.

  • Is the Emory Cardiac Toolbox 2.1 a single-use or reusable device?

    As a software system, it is not a physical consumable; it is intended for repeated use on nuclear medicine computers for ongoing cardiac imaging analysis.

  • What regulatory pathway was used for the Emory Cardiac Toolbox 2.1?

    It received FDA 510(k) clearance under K014033 with a traditional clearance type, indicating it was found substantially equivalent to a predicate device.

  • What is the device classification and medical specialty for the Emory Cardiac Toolbox 2.1?

    It is classified as a Class II medical device and falls under the radiology medical specialty, specifically for use in nuclear cardiology.