Cleared Traditional

K982955 - SILHOUETTE VR

K982955 is an FDA 510(k) clearance for SILHOUETTE VR, 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 72-day FDA review.

K982955 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
72d
Days
Class 2
Risk

K982955 is an FDA 510(k) clearance for the SILHOUETTE VR. 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 November 4, 1998 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K982955

510(k) Number K982955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1998
Decision Date November 04, 1998
Days to Decision 72 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
35d faster than avg
Panel avg: 107d · This submission: 72d
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 K982955.
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DIGITAL RADIOGRAPHIC IMAGING SYSTEM
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K981056 · Varian Medical Systems, Inc. · Jun 1998