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FDA 510(k)

BodyTom 64 (NL4100); OmniTom Elite (NL5000)

K-Number: K261125 · 2026-09-22

ApplicantSamsung HME America, Inc., dba NeuroLogica Corp.
Decision Date2026-09-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BodyTom 64 (NL4100); OmniTom Elite (NL5000) is the device name listed in this FDA 510(k) record. The listed applicant is Samsung HME America, Inc., dba NeuroLogica Corp.. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K261125. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

BodyTom 64 (NL4100); OmniTom Elite (NL5000) is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Samsung HME America, Inc., dba NeuroLogica Corp.. The 510(k) number is K261125.

When did BodyTom 64 (NL4100); OmniTom Elite (NL5000) receive FDA 510(k) clearance?

BodyTom 64 (NL4100); OmniTom Elite (NL5000) received FDA 510(k) clearance on 2026-09-22, under 510(k) number K261125.

Who is the listed applicant for BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

The FDA 510(k) record lists Samsung HME America, Inc., dba NeuroLogica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

The FDA product code for BodyTom 64 (NL4100); OmniTom Elite (NL5000) is JAK.

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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