Cleared Traditional

RALCO

K110856 · Ralco S.R.L. · Radiology
Aug 2011
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K110856 is an FDA 510(k) clearance for the RALCO, a Collimator, Manual, Radiographic (Class II — Special Controls, product code IZX), submitted by Ralco S.R.L. (Naples, US). The FDA issued a Cleared decision on August 10, 2011, 135 days after receiving the submission on March 28, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K110856 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2011
Decision Date August 10, 2011
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZX — Collimator, Manual, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610