Cleared Abbreviated

SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES

K001517 · Shimadzu Corp. · Radiology
Jun 2000
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K001517 is an FDA 510(k) clearance for the SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES, 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 27, 2000, 42 days after receiving the submission on May 16, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K001517 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2000
Decision Date June 27, 2000
Days to Decision 42 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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