Cleared Traditional

K932342 - MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER

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

FDA 510(k) Submission Details - K932342

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

LNN Device Classification - Class ,

Product Code LNN
Device Class -