Cleared Traditional

K023613 - AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036

K023613 is an FDA 510(k) clearance for AX200 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 87-day FDA review.

K023613 · Alphatek Corp. · Radiology device
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Jan 2003
Decision
87d
Days
Class 2
Risk

K023613 is an FDA 510(k) clearance for the AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Alphatek Corp. (Broadview, US). The FDA issued a Cleared decision on January 23, 2003 after a review of 87 days - a notably fast clearance cycle.

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: 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 Alphatek Corp. devices

FDA 510(k) Submission Details - K023613

510(k) Number K023613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date January 23, 2003
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K023613.
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