CardIQ Suite
K213725GE Medical Systems SCS · cleared 2022-03-11 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“CardIQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart.”
source quote (p.6)
“The calcium segmentation/labeling is using a new deep learning algorithm.”
Validation studies (2)
Bench
sample size not stated
endpoints: algorithm's capability to automatically segment, label and score the calcific regions in the coronary arteries
standards: 21CFR 820, ISO 13485, NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard
Reader study (MRMC)
sample size not stated
endpoints: correlation between manual and automated methods for computing the total calcium score; equivalent performance of the CardIQ Suite software to the predicate device SmartScore 4.0
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98738
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243672 (decision 2025-06-18) from GE Medical Systems SCS for a matching device line ("CardIQ Suite") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243672
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233731 (decision 2024-08-01) from GE Medical Systems SCS for a matching device line ("CardIQ Suite") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233731
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- …and 5 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).