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FDA 510(k)

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

K-Number: K231870 · 2023-12-13

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2023-12-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2023-12-13 under approval number K231870. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K231870.

When was CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System approved by the FDA?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System received FDA 510(k) clearance on 2023-12-13, under approval number K231870.

What company makes CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is manufactured by Ge Medical Systems Information Technologies, Inc..

What is the FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

The FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is DQK.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025) PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024) PMID: 40058872 Monocyte activation test (MAT) as an ethical alternative to animal testing. BMB reports (2025)

Other Devices by Ge Medical Systems Information Technologies, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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