Cleared Traditional

Discovery MI Gen2

K211846 · Ge Medical Systems, LLC · Radiology
Aug 2021
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K211846 is an FDA 510(k) clearance for the Discovery MI Gen2, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 20, 2021, 66 days after receiving the submission on June 15, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K211846 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2021
Decision Date August 20, 2021
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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