Cleared Abbreviated

SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION

K090268 · Shimadzu Corp. · Radiology
Jun 2009
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K090268 is an FDA 510(k) clearance for the SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on June 30, 2009, 147 days after receiving the submission on February 3, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K090268 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2009
Decision Date June 30, 2009
Days to Decision 147 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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