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Emory Cardiac Tool Box

by Emory University

510(k) K980914

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 NumberK980914 Date4 Jun 1998ClearedStatusActive

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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Emory Cardiac Tool Box is a system for computed emission tomography used for cardiovascular quantification. It provides 2D and 3D image displays and a suite of specialized analysis tools for both SPECT and PET studies.

This device is authorized under FDA 510K clearance. It is intended for use by medical professionals in a clinical setting.

Other devices from Emory University

Questions

AI-generated answers, 26 Sep 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 the primary purpose of the Emory Cardiac Tool Box?

    The Emory Cardiac Tool Box is a system designed for computed emission tomography. It is used by medical professionals for cardiovascular quantification, providing specialized analysis tools and both 2D and 3D image displays for SPECT and PET studies.

  • Who is the intended user for this device?

    This system is intended for use by medical professionals within a clinical setting to assist in the analysis and quantification of cardiovascular imaging data.

  • What is the regulatory status of this device?

    The Emory Cardiac Tool Box is authorized under FDA 510K clearance, which indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.