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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261677

510(k) cleared

Artificial Intelligence Renal Assessment (AIRA) Version 1

Aramis Global AI Consultancies, LLC · Sep 15, 2026 · K261677

FDA cleared the Artificial Intelligence Renal Assessment (AIRA) Version 1 from Aramis Global AI Consultancies, LLC on Sep 15, 2026 under K261677, 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 21, 2026. The decision came 117 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 Aramis Global AI Consultancies, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261677?

K261677 is the FDA 510(k) for Artificial Intelligence Renal Assessment (AIRA) Version 1, submitted by Aramis Global AI Consultancies, LLC. FDA's decision date was Sep 15, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Artificial Intelligence Renal Assessment (AIRA) Version 1?

Aramis Global AI Consultancies, LLC, based in Dubai, is the applicant of record for K261677.

How long did the K261677 review take?

FDA received the submission on May 21, 2026 and issued its decision on Sep 15, 2026, 117 days later.

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