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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 / K262134

510(k) cleared

NeuroDR

Deep Reasoning Ai, Inc. · Oct 7, 2026 · K262134

FDA cleared the NeuroDR from Deep Reasoning Ai, Inc. on Oct 7, 2026 under K262134, 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 Jun 25, 2026. The decision came 104 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 Deep Reasoning Ai, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262134?

K262134 is the FDA 510(k) for NeuroDR, submitted by Deep Reasoning Ai, Inc.. FDA's decision date was Oct 7, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the NeuroDR?

Deep Reasoning Ai, Inc., based in Sarasota, FL, is the applicant of record for K262134.

How long did the K262134 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Oct 7, 2026, 104 days later.

← All decisions in October 2026