Cleared Abbreviated

SHIMADZU COLLIMATOR R-300

K101039 · Shimadzu Corp. · Radiology
Sep 2010
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K101039 is an FDA 510(k) clearance for the SHIMADZU COLLIMATOR R-300, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on September 20, 2010, 159 days after receiving the submission on April 14, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K101039 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2010
Decision Date September 20, 2010
Days to Decision 159 days
Submission Type Abbreviated
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