Cleared Traditional

K905653 - ADVANTX AFM ANGIO SYSTEM S1808

K905653 is an FDA 510(k) clearance for ADVANTX AFM ANGIO SYSTEM S1808, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K905653 · GE Medical Systems · Radiology device
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May 1991
Decision
148d
Days
Class 2
Risk

K905653 is an FDA 510(k) clearance for the ADVANTX AFM ANGIO SYSTEM S1808. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 - K905653

510(k) Number K905653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date May 15, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 107d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 114
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K905653.
ADVANCE DISPOSABLE CONTROL SYRINGE
K911732 · Advance Medical Designs, Inc. · Sep 1991
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120 · Siemens Medical Solutions USA, Inc. · Aug 1991
PHILIPS INTEGRIS V3000 AND V4000
K910370 · Philips Medical Systems, Inc. · May 1991
NAMIC CONTRAST SAVINGS DELIVERY SYSTEM
K903493 · North American Instrument Corp. · Mar 1991
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
K903941 · Shimadzu Medical Systems · Feb 1991
CATHETERIZATION C-ARM SUPPORT MH-51B(F)
K903371 · Shimadzu Medical Systems · Nov 1990