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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K253770

510(k) cleared

CardIQ Suite

GE Medical Systems SCS · Jul 21, 2026 · K253770

FDA cleared the CardIQ Suite from GE Medical Systems SCS on Jul 21, 2026 under K253770, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 26, 2025. The decision came 237 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems SCS has 2 other decisions in the tracker over the last 12 months: K260087 (Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright), K251199 (Allia Moveo).

Questions & Answers

What did FDA clear under K253770?

K253770 is the FDA 510(k) for CardIQ Suite, submitted by GE Medical Systems SCS. FDA's decision date was Jul 21, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the CardIQ Suite?

GE Medical Systems SCS, based in Buc, is the applicant of record for K253770.

How long did the K253770 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Jul 21, 2026, 237 days later.

← All decisions in July 2026

Sources