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The Tracker / September 2026 / K251417

510(k) cleared

ReVISION 2

Argus Cognitive, Inc. · Sep 9, 2026 · K251417 · In the directory

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.

Argus Cognitive, Inc. has one other decision in the tracker over the last 12 months: K260064 (Neurora).

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. The company is listed in the MedDevice Startups directory.

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.

← All decisions in September 2026

Sources

In the startup directory

Argus Cognitive

Diagnostics & IVD · Hanover, NH