Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BodyTom Elite (NL4000)

K-Number: K253450 · 2026-07-28

ApplicantNeuroLogica Corp., a Samsung Company
Decision Date2026-07-28
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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) received FDA 510(k) clearance on 2026-07-28, under 510(k) number 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.

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.

K253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.K253686True Definition DLGe Healthcare Japan Corporation

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.

↑