Cleared Traditional

MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR

K072780 · Ralco S.R.L. · Radiology

Nov 2007

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K072780 is an FDA 510(k) clearance for the MODEL R302DACS/A 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 November 26, 2007, 59 days after receiving the submission on September 28, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number	K072780 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2007
Decision Date	November 26, 2007
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF