Cleared Special

ODYSSEY WORKSTATION

K093092 · Stereotaxis, Inc. · Cardiovascular
Jan 2010
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K093092 is an FDA 510(k) clearance for the ODYSSEY WORKSTATION, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 21, 2010, 112 days after receiving the submission on October 1, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K093092 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2009
Decision Date January 21, 2010
Days to Decision 112 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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