Cleared Traditional

DAR-3000B

K973342 · Shimadzu Corp. · Radiology
Oct 1997
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K973342 is an FDA 510(k) clearance for the DAR-3000B, 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 8, 1997, 33 days after receiving the submission on September 5, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K973342 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1997
Decision Date October 08, 1997
Days to Decision 33 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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