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Digital Fluoricon Cardiac/Vascular Quantitative

by General Electric Co.

510(k) K863132

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 NumberK863132 Date14 Jan 1987ClearedStatusActive

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  • Withdrawn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, 19 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 Digital Fluoricon Cardiac/Vascular Quantitative is a system for processing and quantifying radiographic images, specifically designed for cardiac and vascular applications. It falls under the category of image processing devices, enabling precise analysis of fluoroscopic images to assess coronary arteries, vascular structures, and related anatomical features.

This device is intended for use in radiology settings, where it processes digital fluoroscopic images to provide quantitative measurements. Supplied as a software-based system, it requires integration with compatible imaging equipment and is not classified as single-use or reusable. Authorized under FDA 510(k) clearance (K863132), it adheres to Class II – Special Controls for radiological image processing systems.

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Questions

AI-generated answers, 19 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 Digital Fluoricon Cardiac/Vascular Quantitative system used for?

    This system processes and quantifies radiographic images specifically for cardiac and vascular applications, enabling precise analysis of fluoroscopic images to assess coronary arteries, vascular structures, and related anatomical features in radiology settings.

  • How is the Digital Fluoricon Cardiac/Vascular Quantitative system supplied?

    The device is supplied as a software-based system that requires integration with compatible imaging equipment to function properly in a radiology environment.

  • Is the Digital Fluoricon Cardiac/Vascular Quantitative system single-use or reusable?

    The device is not classified as single-use or reusable, as it is a software-based system designed for ongoing use in radiology settings when integrated with appropriate imaging equipment.

  • What is the regulatory status of the Digital Fluoricon Cardiac/Vascular Quantitative system?

    The device has received FDA 510(k) clearance (K863132) and is classified under Class II – Special Controls for radiological image processing systems, with a decision description of Substantially Equivalent.