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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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).

This is the only decision on file for Spectrawave, Inc. in the last 12 months of the tracker.

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