Cleared Traditional

K253770 - CardIQ Suite

K253770 is the FDA 510(k) clearance for CardIQ Suite by GE Medical Systems SCS. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K253770 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
237d
Days
Class 2
Risk

K253770 is an FDA 510(k) clearance for the CardIQ Suite. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on July 21, 2026 after a review of 237 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems SCS devices

Submission Details

510(k) Number K253770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2025
Decision Date July 21, 2026
Days to Decision 237 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 107d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K253770.
Enhanced Boundary for PCCT
K253560 · Ge Medical Systems, LLC · Jun 2026
Respiratory Gating for Scanners (2.1)
K253026 · Varian Medical Systems, Inc. · Jun 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
K253596 · Canon Medical Systems Corporation · May 2026
Spectral CT Verida Family
K253649 · Philips Medical Systems Technologies , Ltd. · Mar 2026
CT Rembra RT
K252992 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2026
True Definition DL
K253686 · Ge Healthcare Japan Corporation · Mar 2026