Cleared Traditional

K981880 - DX-480, ADD ON DIGITAL IMAGER

K981880 is an FDA 510(k) clearance for DX-480, manufactured by Wuestec Medical, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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

FDA 510(k) Submission Details - K981880

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
Combination Product No
PCCP Authorized No
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.

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 219
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K981880.
FV-RF
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DIGITAL RADIOGRAPHIC IMAGING SYSTEM
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PHILIPS THORAVISION
K981657 · Philips Medical Systems North America, Inc. · Jun 1998
VARIAN XIMATRON SCAN VISION CT
K981056 · Varian Medical Systems, Inc. · Jun 1998