BodyTom Elite (NL4000)— 510(k) K253450

Name: FDA 510(k) clearance K253450
Creator: U.S. Food and Drug Administration
Published: 2026-07-28

Substantially Equivalent

NeuroLogica Corp., a Samsung Company

FDA 510(k) clearance K253450 for BodyTom Elite (NL4000), Substantially Equivalent on 2026-07-28. Applicant: NeuroLogica Corp., a Samsung Company. Device class: 2.

Clearance details

Applicant: NeuroLogica Corp., a Samsung Company
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2025-10-02
Decision date: 2026-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.