Cleared Abbreviated

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE

K032443 · Shimadzu Corp. · Radiology
Feb 2004
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K032443 is an FDA 510(k) clearance for the DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE, 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 February 20, 2004, 196 days after receiving the submission on August 8, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K032443 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2003
Decision Date February 20, 2004
Days to Decision 196 days
Submission Type Abbreviated
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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