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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 / May 2026 / K253181

510(k) cleared

SURGIMAGE SIM 1000H Fluorescence Imaging Platform

Surgimage Corporation · May 13, 2026 · K253181

FDA cleared the SURGIMAGE SIM 1000H Fluorescence Imaging Platform from Surgimage Corporation on May 13, 2026 under K253181, a traditional 510(k). The device falls under product code IZI, System, X-Ray, Angiographic, regulated at 21 CFR 892.1600 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 26, 2025. The decision came 229 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Surgimage Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253181?

K253181 is the FDA 510(k) for SURGIMAGE SIM 1000H Fluorescence Imaging Platform, submitted by Surgimage Corporation. FDA's decision date was May 13, 2026, under product code IZI (System, X-Ray, Angiographic).

Who makes the SURGIMAGE SIM 1000H Fluorescence Imaging Platform?

Surgimage Corporation, based in Taipei City, is the applicant of record for K253181.

How long did the K253181 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on May 13, 2026, 229 days later.

← All decisions in May 2026