Cleared Traditional

K964952 - VERIDOSE V (FIVE), MODEL NUMBER 37-705 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964952 · Victoreen, Inc. · Radiology device
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Jul 1997
Decision
223d
Days
Class 2
Risk

K964952 is an FDA 510(k) clearance for the VERIDOSE V (FIVE), MODEL NUMBER 37-705. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 21, 1997 after a review of 223 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Victoreen, Inc. devices

Submission Details

510(k) Number K964952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1996
Decision Date July 21, 1997
Days to Decision 223 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 107d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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.