Cleared Abbreviated

BRANSIST SAFIRE

K062360 · Shimadzu Corp. · Radiology
Oct 2006
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K062360 is an FDA 510(k) clearance for the BRANSIST 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 October 5, 2006, 52 days after receiving the submission on August 14, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K062360 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2006
Decision Date October 05, 2006
Days to Decision 52 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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