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The Tracker / September 2025 / K250928

510(k) cleared

OmniTom Elite with PCD

Neurologica Corporation · Sep 8, 2025 · K250928

FDA cleared the OmniTom Elite with PCD from Neurologica Corporation on Sep 8, 2025 under K250928, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 28, 2025. The decision came 164 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 Neurologica Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250928?

K250928 is the FDA 510(k) for OmniTom Elite with PCD, submitted by Neurologica Corporation. FDA's decision date was Sep 8, 2025, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the OmniTom Elite with PCD?

Neurologica Corporation, based in Danvers, MA, is the applicant of record for K250928.

How long did the K250928 review take?

FDA received the submission on Mar 28, 2025 and issued its decision on Sep 8, 2025, 164 days later.

← All decisions in September 2025