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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 / September 2025 / K243645

510(k) cleared

IC-Flow Imaging System 2.0

Diagnostic Green GmbH · Sep 22, 2025 · K243645

FDA cleared the IC-Flow Imaging System 2.0 from Diagnostic Green GmbH on Sep 22, 2025 under K243645, 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 Nov 26, 2024. The decision came 300 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 Diagnostic Green GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243645?

K243645 is the FDA 510(k) for IC-Flow Imaging System 2.0, submitted by Diagnostic Green GmbH. FDA's decision date was Sep 22, 2025, under product code IZI (System, X-Ray, Angiographic).

Who makes the IC-Flow Imaging System 2.0?

Diagnostic Green GmbH, based in Kirchheim B. München, is the applicant of record for K243645.

How long did the K243645 review take?

FDA received the submission on Nov 26, 2024 and issued its decision on Sep 22, 2025, 300 days later.

← All decisions in September 2025