Cleared Traditional

GE OEC ALTITUDE

K071717 · Shimadzu Corp. · Radiology
Jul 2007
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K071717 is an FDA 510(k) clearance for the GE OEC ALTITUDE, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Shimadzu Corp. (Kyoto, JP). The FDA issued a Cleared decision on July 5, 2007, 13 days after receiving the submission on June 22, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K071717 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2007
Decision Date July 05, 2007
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

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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