Cleared Traditional

K981880 - DX-480, ADD ON DIGITAL IMAGER (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981880 · Wuestec Medical, Inc. · Radiology device
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Oct 1998
Decision
145d
Days
Class 2
Risk

K981880 is an FDA 510(k) clearance for the DX-480, ADD ON DIGITAL IMAGER. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on October 20, 1998 after a review of 145 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.

View all Wuestec Medical, Inc. devices

Submission Details

510(k) Number K981880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date October 20, 1998
Days to Decision 145 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 107d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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