Cleared Abbreviated

SHIMADZU COLLIMATOR R-30H

K090578 · Shimadzu Corp. · Radiology
Nov 2009
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K090578 is an FDA 510(k) clearance for the SHIMADZU COLLIMATOR R-30H, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on November 6, 2009, 248 days after receiving the submission on March 3, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K090578 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2009
Decision Date November 06, 2009
Days to Decision 248 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement

Device Classification

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