Cleared Traditional

K931883 - AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033

K931883 is an FDA 510(k) clearance for AX-390SE AUTOMATIC X-RAY FILM PROCESSOR..., manufactured by Alphatek Corp.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K931883 · Alphatek Corp. · Radiology device
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Aug 1993
Decision
131d
Days
Class 2
Risk

K931883 is an FDA 510(k) clearance for the AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Alphatek Corp. (Chicago, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 Alphatek Corp. devices

FDA 510(k) Submission Details - K931883

510(k) Number K931883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date August 23, 1993
Days to Decision 131 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
24d slower than avg
Panel avg: 107d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 51
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