Cleared Traditional

K894142 - ULTRANET-S COLLIMATOR

K894142 is an FDA 510(k) clearance for ULTRANET-S COLLIMATOR, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code IZW cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K894142 · GE Medical Systems · Radiology device
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Nov 1989
Decision
146d
Days
Class 2
Risk

K894142 is an FDA 510(k) clearance for the ULTRANET-S COLLIMATOR. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 6, 1989 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 892.1610 - 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 - K894142

510(k) Number K894142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1989
Decision Date November 06, 1989
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
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.

IZW Device Classification - Class 2, Special Controls

Product Code IZW Collimator, Automatic, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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.