Cleared Traditional

K943355 - GEMNET

K943355 is an FDA 510(k) clearance for GEMNET, 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 118-day FDA review.

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

FDA 510(k) Submission Details - K943355

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.

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 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