Cleared Traditional

GEMNET (K943355) - FDA 510(k) Clearance

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

K943355 · GE Medical Systems · Radiology device
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Nov 1994
Decision
118d
Days
Class 2
Risk

K943355 is an FDA 510(k) clearance for the GEMNET. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on November 7, 1994 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 892.1600 - 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 K943355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date November 07, 1994
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 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 K943355.
DLX
K945459 · General Electric Co. · Jan 1995
TOP ACOM STATION
K945293 · Siemens Medical Solutions USA, Inc. · Jan 1995
COMPAS
K945483 · General Electric Co. · Dec 1994
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K942120 · GE Medical Systems · Jul 1994
ANGIOREX CAS-05A
K941177 · Toshiba America Medical Systems, In.C · Jun 1994
LCA ANGIOGRAPHIC IMAGING SYSTEM
K941946 · GE Medical Systems · May 1994