CardIQ Suite
K-Number: K213725 · 2022-03-11
ApplicantGE Medical Systems SCS
Decision Date2022-03-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CardIQ Suite is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2022-03-11 under approval number K213725. 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 2022-03-11. It is manufactured by GE Medical Systems SCS. The 510(k) number is K213725.
When was CardIQ Suite approved by the FDA?
CardIQ Suite received FDA 510(k) clearance on 2022-03-11, under approval number K213725.
What company makes CardIQ Suite?
CardIQ Suite is manufactured by GE Medical Systems SCS.
What is the FDA product code for CardIQ Suite?
The FDA product code for CardIQ Suite is JAK.
Other Devices by GE Medical Systems SCS
Related Devices (Code: JAK)
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.
K163213Revolution CTGe Medical Systems, LLC
K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.
K160723OnSight 3D Extremity SystemCarestream Health, Inc.
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.
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.