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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 / October 2026 / K261042

510(k) cleared

Lung Guidance

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Oct 2, 2026 · K261042

FDA cleared the Lung Guidance from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC on Oct 2, 2026 under K261042, a traditional 510(k). The device falls under product code QJU, Image Acquisition And/Or Optimization Guided By Artificial Intelligence, regulated at 21 CFR 892.2100 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 31, 2026. The decision came 185 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has 2 other decisions in the tracker over the last 12 months: K252718 (Lunar Astra), K254161 (Automated Aortic Stenosis Software (AutoAS)).

Questions & Answers

What did FDA clear under K261042?

K261042 is the FDA 510(k) for Lung Guidance, submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. FDA's decision date was Oct 2, 2026, under product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence).

Who makes the Lung Guidance?

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, based in Waukesha, WI, is the applicant of record for K261042.

How long did the K261042 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Oct 2, 2026, 185 days later.

← All decisions in October 2026

Sources