Cleared Traditional

ADVANTX AFM ANGIO SYSTEM S1808 (K905653) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 53
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K905653.
DXS DIGITAL X-RAY SUBTRACTION
K914376 · Philips Medical Systems (Cleveland), Inc. · Feb 1992
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
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115 · Toshiba America Medical Systems, In.C · Mar 1990
LC, CARDIAC POSITIONER #B5078A
K890348 · General Electric Co. · Feb 1989
MULTISKOP
K890352 · Siemens Medical Solutions USA, Inc. · Feb 1989