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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 / March 2026 / K260087

510(k) cleared

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright

GE Medical Systems SCS · Mar 24, 2026 · K260087

FDA cleared the Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright from GE Medical Systems SCS on Mar 24, 2026 under K260087, a traditional 510(k). The device falls under product code MUE, Full Field Digital, System, X-Ray, Mammographic, regulated at 21 CFR 892.1715 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 12, 2026. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

GE Medical Systems SCS has 2 other decisions in the tracker over the last 12 months: K253770 (CardIQ Suite), K251199 (Allia Moveo).

Questions & Answers

What did FDA clear under K260087?

K260087 is the FDA 510(k) for Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright, submitted by GE Medical Systems SCS. FDA's decision date was Mar 24, 2026, under product code MUE (Full Field Digital, System, X-Ray, Mammographic).

Who makes the Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright?

GE Medical Systems SCS, based in Buc, is the applicant of record for K260087.

How long did the K260087 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Mar 24, 2026, 71 days later.

← All decisions in March 2026

Sources