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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 / January 2026 / K251670

510(k) cleared

MAC 7 Resting ECG Analysis System

Ge Medical Systems Information Technologies, Inc. · Jan 26, 2026 · K251670

FDA cleared the MAC 7 Resting ECG Analysis System from Ge Medical Systems Information Technologies, Inc. on Jan 26, 2026 under K251670, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 30, 2025. The decision came 241 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ge Medical Systems Information Technologies, Inc. has one other decision in the tracker over the last 12 months: K253277 (Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P).

Questions & Answers

What did FDA clear under K251670?

K251670 is the FDA 510(k) for MAC 7 Resting ECG Analysis System, submitted by Ge Medical Systems Information Technologies, Inc.. FDA's decision date was Jan 26, 2026, under product code DPS (Electrocardiograph).

Who makes the MAC 7 Resting ECG Analysis System?

Ge Medical Systems Information Technologies, Inc., based in Wauwatosa, WI, is the applicant of record for K251670.

How long did the K251670 review take?

FDA received the submission on May 30, 2025 and issued its decision on Jan 26, 2026, 241 days later.

← All decisions in January 2026

Sources