Cleared Traditional

K930273 - ALPHA

K930273 is an FDA 510(k) clearance for ALPHA, manufactured by Raymax Medical Corp.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K930273 · Raymax Medical Corp. · Radiology device
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Jul 1993
Decision
175d
Days
Class 2
Risk

K930273 is an FDA 510(k) clearance for the ALPHA. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Raymax Medical Corp. (Ontario, L4l 7k5, CA). The FDA issued a Cleared decision on July 13, 1993 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Raymax Medical Corp. devices

FDA 510(k) Submission Details - K930273

510(k) Number K930273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date July 13, 1993
Days to Decision 175 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
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IZZ Table, Radiographic, Non-tilting, Powered

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