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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260879

510(k) cleared

4DM

INVIA, LLC · Sep 10, 2026 · K260879

FDA cleared the 4DM from INVIA, LLC on Sep 10, 2026 under K260879, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 17, 2026. The decision came 177 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 INVIA, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260879?

K260879 is the FDA 510(k) for 4DM, submitted by INVIA, LLC. FDA's decision date was Sep 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the 4DM?

INVIA, LLC, based in Ann Arbor, MI, is the applicant of record for K260879.

How long did the K260879 review take?

FDA received the submission on Mar 17, 2026 and issued its decision on Sep 10, 2026, 177 days later.

← All decisions in September 2026