Cleared Traditional

K932342 - MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER (FDA 510(k) Clearance)

K932342 · Victoreen, Inc. · Radiology device
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Dec 1993
Decision
213d
Days
-
Risk

K932342 is an FDA 510(k) clearance for the MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER.

Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 213 days - an extended review cycle.

This device falls under the Radiology FDA review panel. 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 Victoreen, Inc. devices

Submission Details

510(k) Number K932342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1993
Decision Date December 13, 1993
Days to Decision 213 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
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LNN
Device Class -