Cleared Traditional

SOPIX 2

K092329 · Sopro · Radiology
Jul 2010
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K092329 is an FDA 510(k) clearance for the SOPIX 2, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Sopro (Mt. Laurel, US). The FDA issued a Cleared decision on July 20, 2010, 350 days after receiving the submission on August 4, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K092329 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2009
Decision Date July 20, 2010
Days to Decision 350 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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