Cleared Traditional

BodyTom 64 (K213649) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213649 · Neurologica Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
161d
Days
Class 2
Risk

K213649 is an FDA 510(k) clearance for the BodyTom 64. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Neurologica Corporation (Danvers, US). The FDA issued a Cleared decision on April 29, 2022 after a review of 161 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 Corporation devices

Submission Details

510(k) Number K213649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2021
Decision Date April 29, 2022
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
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 427
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K213649.
XACT ACE Robotic System
K221116 · Xact Robotics, Ltd. · May 2022
NewTom 7G
K220664 · Cefla S.C. · May 2022
Liver Suite
K211180 · GE Medical Systems SCS · May 2022
Philips Incisive CT
K212441 · Philips Healthcare (Suzhou) Co., Ltd. · Apr 2022
HealthOST
K213944 · Nanoxai , Ltd. · Apr 2022
Syngo.CT Dual Energy
K212889 · Siemens Medical Solutions USA, Inc. · Mar 2022