Cleared Traditional

K900932 - 37-702 AND 37-703 PC RAINBOW (FDA 510(k) Clearance)

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

K900932 · Victoreen, Inc. · Radiology device
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Dec 1990
Decision
280d
Days
Class 2
Risk

K900932 is an FDA 510(k) clearance for the 37-702 AND 37-703 PC RAINBOW. Classified as Collimator, Orthovoltage, Therapeutic X-ray (product code IYI), Class II - Special Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 280 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 K900932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1990
Decision Date December 05, 1990
Days to Decision 280 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 107d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYI Collimator, Orthovoltage, 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.