FDA 510(k)

BodyTom 64 (NL4100); OmniTom Elite (NL5000)

K-Nummer: K261125 · 2026-09-22

AntragstellerSamsung HME America, Inc., dba NeuroLogica Corp.

Entscheidungsdatum2026-09-22

ProduktcodeJAK

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: JAK)

K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.

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