Cleared Abbreviated

DAR-9400F

K072006 · Shimadzu Corp. · Radiology
Aug 2007
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K072006 is an FDA 510(k) clearance for the DAR-9400F, 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 August 31, 2007, 39 days after receiving the submission on July 23, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K072006 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2007
Decision Date August 31, 2007
Days to Decision 39 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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