Cleared Traditional

K253450 - BodyTom Elite (NL4000)

K253450 is the FDA 510(k) clearance for BodyTom Elite (NL4000) by NeuroLogica Corp., a Samsung Company. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K253450 · NeuroLogica Corp., a Samsung Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
299d
Days
Class 2
Risk

K253450 is an FDA 510(k) clearance for the BodyTom Elite (NL4000). Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by NeuroLogica Corp., a Samsung Company (Danvers, US). The FDA issued a Cleared decision on July 28, 2026 after a review of 299 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all NeuroLogica Corp., a Samsung Company devices

Submission Details

510(k) Number K253450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2025
Decision Date July 28, 2026
Days to Decision 299 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 107d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 582
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