Cleared Traditional

K133640 - ASIR-V

K133640 is the FDA 510(k) clearance for ASIR-V by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K133640 · Ge Medical Systems, LLC · Radiology device
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Mar 2014
Decision
118d
Days
Class 2
Risk

K133640 is an FDA 510(k) clearance for the ASIR-V. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on March 25, 2014 after a review of 118 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, LLC devices

Submission Details

510(k) Number K133640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2013
Decision Date March 25, 2014
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K133640.
SOMATOM FORCE
K133589 · Siemens Medical Solutions USA, Inc. · Apr 2014
REVOLUTION CT
K133705 · Ge Medical Systems, LLC · Apr 2014
SYNGO DUAL ENERGY SOFTWARE PACKAGE
K132902 · Siemens Medical Solutions USA, Inc. · Apr 2014
AQUILION ONE VISION
K133497 · Toshibamedical Systems Corporation · Feb 2014
DUAL ENERGY SYSTEM PACKAGE
K132813 · Toshibamedical Systems Corporation · Feb 2014
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
K132410 · Ge Medical Systems, LLC · Jan 2014