Cleared Traditional

K041763 - SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
(FDA 510(k) Clearance)

K041763 · Shimadzu Corp. · Radiology

Jul 2004

Decision

13d

Days

Class 2

Risk

K041763 is an FDA 510(k) clearance for the SHIMADZU MOBILE X-RAY SYSTEM MUX-100D 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 July 13, 2004, 13 days after receiving the submission on June 30, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K041763 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2004
Decision Date	July 13, 2004
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement