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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 / K251417

510(k) cleared

ReVISION 2

Argus Cognitive, Inc. · Sep 9, 2026 · K251417

FDA cleared the ReVISION 2 from Argus Cognitive, Inc. on Sep 9, 2026 under K251417, 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 May 7, 2025. The decision came 490 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 Argus Cognitive, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251417?

K251417 is the FDA 510(k) for ReVISION 2, submitted by Argus Cognitive, Inc.. FDA's decision date was Sep 9, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the ReVISION 2?

Argus Cognitive, Inc., based in Hanover, NH, is the applicant of record for K251417.

How long did the K251417 review take?

FDA received the submission on May 7, 2025 and issued its decision on Sep 9, 2026, 490 days later.

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