Cleared Traditional

RALCO, MODEL R225 ACS

K091517 · Ralco S.R.L. · Radiology
Jul 2009
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K091517 is an FDA 510(k) clearance for the RALCO, MODEL R225 ACS, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Ralco S.R.L. (Deerfield, US). The FDA issued a Cleared decision on July 14, 2009, 53 days after receiving the submission on May 22, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K091517 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2009
Decision Date July 14, 2009
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZW — Collimator, Automatic, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610