Cleared Traditional

K980234 - THE NETWORK SYSTEM

K980234 is an FDA 510(k) clearance for THE NETWORK SYSTEM, manufactured by Medical Sni , Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K980234 · Medical Sni , Ltd. · Radiology device
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Jun 1998
Decision
146d
Days
Class 2
Risk

K980234 is an FDA 510(k) clearance for the THE NETWORK SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Medical Sni , Ltd. (Efrat, IL). The FDA issued a Cleared decision on June 17, 1998 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Medical Sni , Ltd. devices

FDA 510(k) Submission Details - K980234

510(k) Number K980234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1998
Decision Date June 17, 1998
Days to Decision 146 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
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1329
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K980234.
PEDIATRIC INSTATRAK SYSTEM
K981998 · Visualization Technology, Inc. · Aug 1998
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K980648 · Algotec Systems, Ltd. · Jul 1998
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
K981217 · GE Medical Systems · Jun 1998
IIRAD DIRECTRAY OPERATOR CONSOLE
K980970 · Sterling Diagnostic Imaging, Inc. · Jun 1998
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
K980168 · Analogic Corp. · Apr 1998
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
K980118 · Eastman Kodak Company · Mar 1998