Cleared Traditional

K946320 - R 302

K946320 is an FDA 510(k) clearance for R 302, manufactured by Ralco S.R.L.. The device is a Class 2 Radiology device with product code KPW cleared through the Traditional 510(k) pathway after a 134-day FDA review.

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

FDA 510(k) Submission Details - K946320

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.

KPW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KPW Device, Beam Limiting, X-ray, Diagnostic

Devices cleared under the same product code (KPW) and FDA review panel - the closest regulatory comparables to K946320.
BLA-800A
K954310 · Toshiba Medical Systems · Oct 1995
TF-63SA
K904044 · Toshiba America Medical Systems, In.C · Nov 1990
RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC
K820306 · Tecnomed, Inc. · Mar 1982
RALCO COLLIMATORS, MANUAL RADIOGRAPHIC
K820305 · Tecnomed, Inc. · Mar 1982
COLLIMATOR, HEART CONTOUR
K781984 · Siemens Corp. · Dec 1978