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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 / December 2025 / K253101

510(k) cleared

HyperVue Imaging System - Integrated

Spectrawave, Inc. · Dec 15, 2025 · K253101

FDA cleared the HyperVue Imaging System - Integrated from Spectrawave, Inc. on Dec 15, 2025 under K253101, a traditional 510(k). The device falls under product code NQQ, System, Imaging, Optical Coherence Tomography (Oct), regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 24, 2025. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

Spectrawave, Inc. has one other decision in the tracker over the last 12 months: K251355 (X1-FFR).

Questions & Answers

What did FDA clear under K253101?

K253101 is the FDA 510(k) for HyperVue Imaging System - Integrated, submitted by Spectrawave, Inc.. FDA's decision date was Dec 15, 2025, under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)).

Who makes the HyperVue Imaging System - Integrated?

Spectrawave, Inc., based in Bedford, MA, is the applicant of record for K253101.

How long did the K253101 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Dec 15, 2025, 82 days later.

← All decisions in December 2025

Sources