Cleared Traditional

HEPATIC VCAR (K133649) - FDA 510(k) Clearance

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

K133649 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
146d
Days
Class 2
Risk

K133649 is an FDA 510(k) clearance for the HEPATIC VCAR. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Waukesha, US). The FDA issued a Cleared decision on April 22, 2014 after a review of 146 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 GE Medical Systems SCS devices

Submission Details

510(k) Number K133649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2013
Decision Date April 22, 2014
Days to Decision 146 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
39d slower than avg
Panel avg: 107d · This submission: 146d
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 352
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K133649.
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232 · Siemens Medical Solutions USA, Inc. · Aug 2014
SYNGO, CT DUAL ENERGY
K133648 · Siemens Medical Solutions USA, Inc. · Jul 2014
SOMATOM PERSPECTIVE
K133590 · Siemens Medical Solutions USA, Inc. · Apr 2014
SOMATOM FORCE
K133589 · Siemens Medical Solutions USA, Inc. · Apr 2014
SYNGO DUAL ENERGY SOFTWARE PACKAGE
K132902 · Siemens Medical Solutions USA, Inc. · Apr 2014
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
K133424 · Siemens Medical Solutions USA, Inc. · Jan 2014