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The Tracker / September 2026 / K261125

510(k) cleared

BodyTom 64 (NL4100); OmniTom Elite (NL5000)

Samsung HME America, Inc., dba NeuroLogica Corp. · Sep 22, 2026 · K261125

FDA cleared the BodyTom 64 (NL4100); OmniTom Elite (NL5000) from Samsung HME America, Inc., dba NeuroLogica Corp. on Sep 22, 2026 under K261125, 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 Apr 6, 2026. The decision came 169 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 Samsung HME America, Inc., dba NeuroLogica Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261125?

K261125 is the FDA 510(k) for BodyTom 64 (NL4100); OmniTom Elite (NL5000), submitted by Samsung HME America, Inc., dba NeuroLogica Corp.. FDA's decision date was Sep 22, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

Samsung HME America, Inc., dba NeuroLogica Corp., based in Danvers, MA, is the applicant of record for K261125.

How long did the K261125 review take?

FDA received the submission on Apr 6, 2026 and issued its decision on Sep 22, 2026, 169 days later.

← All decisions in September 2026