Cleared Traditional

K946320 - R 302 (FDA 510(k) Clearance)

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

K946320 · Ralco S.R.L. · Radiology device
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May 1995
Decision
134d
Days
Class 2
Risk

K946320 is an FDA 510(k) clearance for the R 302. Classified as Device, Beam Limiting, X-ray, Diagnostic (product code KPW), Class II - Special Controls.

Submitted by Ralco S.R.L. (Italy, IT). The FDA issued a Cleared decision on May 11, 1995 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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 Ralco S.R.L. devices

Submission Details

510(k) Number K946320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date May 11, 1995
Days to Decision 134 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
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPW Device, Beam Limiting, X-ray, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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.