Cleared Traditional

K982196 - DIGITAL RADIOGRAPHIC IMAGING SYSTEM

K982196 is an FDA 510(k) clearance for DIGITAL RADIOGRAPHIC IMAGING SYSTEM, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K982196 · GE Medical Systems · Radiology device
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Oct 1998
Decision
106d
Days
Class 2
Risk

K982196 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHIC IMAGING SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on October 6, 1998 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

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FDA 510(k) Submission Details - K982196

510(k) Number K982196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date October 06, 1998
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 192
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K982196.
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PHILIPS THORAVISION
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VARIAN XIMATRON SCAN VISION CT
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VACUDAP, MODEL 2000, 2001
K974112 · Victoreen, Inc. · Jan 1998