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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 / K242314

510(k) cleared

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

Augment Intelligent Medical System (China) Co., Ltd. · Sep 11, 2025 · K242314

FDA cleared the Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) from Augment Intelligent Medical System (China) Co., Ltd. on Sep 11, 2025 under K242314, 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 Aug 5, 2024. The decision came 402 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 Augment Intelligent Medical System (China) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242314?

K242314 is the FDA 510(k) for Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2), submitted by Augment Intelligent Medical System (China) Co., Ltd.. FDA's decision date was Sep 11, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)?

Augment Intelligent Medical System (China) Co., Ltd., based in Nanjing, is the applicant of record for K242314.

How long did the K242314 review take?

FDA received the submission on Aug 5, 2024 and issued its decision on Sep 11, 2025, 402 days later.

← All decisions in September 2025