Cleared Traditional

K974715 - ADVANTAGE 3D XR

K974715 is an FDA 510(k) clearance for ADVANTAGE 3D XR, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K974715 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
201d
Days
Class 2
Risk

K974715 is an FDA 510(k) clearance for the ADVANTAGE 3D XR. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 201 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 GE Medical Systems devices

FDA 510(k) Submission Details - K974715

510(k) Number K974715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1997
Decision Date July 06, 1998
Days to Decision 201 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
94d slower than avg
Panel avg: 107d · This submission: 201d
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 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K974715.
VOLUMAX CT IMAGING SYSTEM
K982060 · Elscint, Inc. · Sep 1998
AQUILION CT SCANNER, MODEL TSX-101A
K982265 · Toshiba America Medical Systems, In.C · Aug 1998
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
K982004 · General Electric Co. · Aug 1998
CT SCOPE
K974344 · Elscint, Inc. · Jun 1998
PINPOINT
K974513 · Philips Medical Systems (Cleveland), Inc. · May 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
K980837 · Shimadzu Medical Systems · May 1998