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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 / K253639

510(k) cleared

View

GE Healthcare · Jan 8, 2026 · K253639

FDA cleared the View from GE Healthcare on Jan 8, 2026 under K253639, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 19, 2025. The decision came 50 days later, inside the 90 FDA-day goal for a 510(k).

GE Healthcare has 2 other decisions in the tracker over the last 12 months: K260502 (Liv Pre-lubricated Intermittent Catheter), K251274 (EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits).

Questions & Answers

What did FDA clear under K253639?

K253639 is the FDA 510(k) for View, submitted by GE Healthcare. FDA's decision date was Jan 8, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the View?

GE Healthcare, based in Chicago, IL, is the applicant of record for K253639.

How long did the K253639 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Jan 8, 2026, 50 days later.

← All decisions in January 2026

Sources