Cleared Traditional

LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400

K033184 · Shimadzu Corp. · Radiology
Dec 2003
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K033184 is an FDA 510(k) clearance for the LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on December 9, 2003, 69 days after receiving the submission on October 1, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K033184 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2003
Decision Date December 09, 2003
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

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