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CARDIS

by Schwarzer GmbH

510(k) K023015

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 NumberK023015 Date25 Sep 2002ClearedStatusActive

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  • Withdrawn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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

CARDIS is a cardiology information system designed for documentation in the cardiac catheterization laboratory. It provides modular workflow support with automatic recording of all processes and consumables during examinations.

The system facilitates straightforward report generation and includes standard interfaces such as DICOM, HL7, ADT, OPS, and BQS. CARDIS is manufactured by Schwarzer GmbH and received FDA 510(k) clearance with K number K023015 on September 25, 2002.

Questions

AI-generated answers, 27 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 CARDIS system designed for?

    CARDIS is a cardiology information system specifically designed for documentation in the cardiac catheterization laboratory, providing modular workflow support and automatic recording of all processes and consumables during examinations.

  • What interfaces does the CARDIS system support?

    The CARDIS system includes standard interfaces such as DICOM, HL7, ADT, OPS, and BQS, facilitating straightforward report generation and integration with other healthcare systems.

  • What is the regulatory status of the CARDIS system?

    CARDIS received FDA 510(k) clearance with K number K023015 on September 25, 2002, and was determined to be substantially equivalent by the Cardiovascular advisory committee.

  • Who manufactures the CARDIS system?

    CARDIS is manufactured by Schwarzer GmbH, located in Munich, Germany, with contact information available through their Baermannstrasse 38 address.