FDA 510(k)

BodyTom Elite (NL4000)

N.º K: K253450 · 2026-07-28

SolicitanteNeuroLogica Corp., a Samsung Company

Fecha de decisión2026-07-28

Código de productoJAK

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

BodyTom Elite (NL4000) is the device name listed in this FDA 510(k) record. The listed applicant is NeuroLogica Corp., a Samsung Company. It received FDA 510(k) clearance on 2026-07-28 under 510(k) number K253450. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BodyTom Elite (NL4000)?

BodyTom Elite (NL4000) is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is NeuroLogica Corp., a Samsung Company. The 510(k) number is K253450.

When did BodyTom Elite (NL4000) receive FDA 510(k) clearance?

BodyTom Elite (NL4000) recibió la aprobación FDA 510(k) el 28 de julio de 2026, bajo el número de 510(k) K253450.

Who is the listed applicant for BodyTom Elite (NL4000)?

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

What is the FDA product code for BodyTom Elite (NL4000)?

The FDA product code for BodyTom Elite (NL4000) is JAK.

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Dispositivos relacionados (Código: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.

Fuente oficial

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