CardIQ Suite— 510(k) K253770
Substantially EquivalentGE Medical Systems SCS
FDA 510(k) clearance K253770 for CardIQ Suite, Substantially Equivalent on 2026-07-21. Applicant: GE Medical Systems SCS. Device class: 2.
Summary
GE Medical Systems SCS's CardIQ Suite is filed under JAK, computed tomography X-ray systems. The record doesn't say what the suite includes.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
GE filed from Buc, France. Review took 237 calendar days (November 26, 2025 to July 21, 2026).
Clearance details
- Applicant
- GE Medical Systems SCS
- Product code
- Product code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buc, FR
Recent devices under product code JAK
view allMore clearances from GE Medical Systems SCS
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.