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FDA 510(k)

CardIQ Suite

K-Number: K253770 · 2026-07-21

ApplicantGE Medical Systems SCS
Decision Date2026-07-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CardIQ Suite is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2026-07-21 under 510(k) number K253770. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardIQ Suite?

CardIQ Suite is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is GE Medical Systems SCS. The 510(k) number is K253770.

When did CardIQ Suite receive FDA 510(k) clearance?

CardIQ Suite received FDA 510(k) clearance on 2026-07-21, under 510(k) number K253770.

Who is the listed applicant for CardIQ Suite?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardIQ Suite?

The FDA product code for CardIQ Suite is JAK.

Other records listing GE Medical Systems SCS as applicant

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Related Devices (Code: JAK)

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K253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.K253686True Definition DLGe Healthcare Japan CorporationK252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.

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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