Cleared Traditional

R 302

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

About This 510(k) Submission

K946320 is an FDA 510(k) clearance for the R 302, a Device, Beam Limiting, X-ray, Diagnostic (Class II — Special Controls, product code KPW), submitted by Ralco S.R.L. (Italy, IT). The FDA issued a Cleared decision on May 11, 1995, 134 days after receiving the submission on December 28, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K946320 FDA.gov
FDA Decision Cleared 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

Device Classification

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