Cleared Traditional

K170238 - BodyTom Elite

K170238 is an FDA 510(k) clearance for BodyTom Elite, manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K170238 · Neurologica Corporation, A Subsidiary of Samsung Electronics · Radiology device
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Jun 2017
Decision
139d
Days
Class 2
Risk

K170238 is an FDA 510(k) clearance for the BodyTom Elite. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Neurologica Corporation, A Subsidiary of Samsung Electronics (Danvers, US). The FDA issued a Cleared decision on June 14, 2017 after a review of 139 days - within the typical 510(k) review window.

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 Corporation, A Subsidiary of Samsung Electronics devices

FDA 510(k) Submission Details - K170238

510(k) Number K170238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2017
Decision Date June 14, 2017
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 640
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K170238.
Philips CT Big Bore
K171850 · Philips Medical Systems (Cleveland), Inc. · Nov 2017
NeuViz Prime Multi-slice CT Scanner System
K171201 · Neusoft Medical Systems Co., Ltd. · Sep 2017
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
K170177 · Toshibamedical Systems Corporation · Jun 2017
syngo.CT Cardiac Planning
K170221 · Siemens Healthcare GmbH · Apr 2017
PercuNav Image Fusion and Interventional Navigation
K170716 · Philips Ultrasound, Inc. · Apr 2017
Philips iCT CT System
K162838 · Philips Medical Systems (Cleveland), Inc. · Apr 2017