Cleared Traditional

MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR

K083029 · Ralco S.R.L. · Radiology
Dec 2008
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K083029 is an FDA 510(k) clearance for the MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Ralco S.R.L. (Deer Field, US). The FDA issued a Cleared decision on December 5, 2008, 56 days after receiving the submission on October 10, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K083029 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2008
Decision Date December 05, 2008
Days to Decision 56 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