Cleared Traditional

SONIC SHOT GX

K091734 · Nemoto Kyorindo Co., Ltd. · Radiology
May 2010
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K091734 is an FDA 510(k) clearance for the SONIC SHOT GX, a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Nemoto Kyorindo Co., Ltd. (Kawaguchi-Shi, Saitama, JP). The FDA issued a Cleared decision on May 21, 2010, 344 days after receiving the submission on June 11, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K091734 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2009
Decision Date May 21, 2010
Days to Decision 344 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZQ — Injector, Contrast Medium, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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