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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 / October 2025 / K251355

510(k) cleared

X1-FFR

Spectrawave, Inc. · Oct 17, 2025 · K251355

FDA cleared the X1-FFR from Spectrawave, Inc. on Oct 17, 2025 under K251355, a traditional 510(k). The device falls under product code QHA, X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, regulated at 21 CFR 892.1600 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 30, 2025. The decision came 170 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spectrawave, Inc. has one other decision in the tracker over the last 12 months: K253101 (HyperVue Imaging System - Integrated).

Questions & Answers

What did FDA clear under K251355?

K251355 is the FDA 510(k) for X1-FFR, submitted by Spectrawave, Inc.. FDA's decision date was Oct 17, 2025, under product code QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device).

Who makes the X1-FFR?

Spectrawave, Inc., based in Bedford, MA, is the applicant of record for K251355.

How long did the K251355 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Oct 17, 2025, 170 days later.

← All decisions in October 2025

Sources