Cleared Traditional

Omni Legend

K221932 · Ge Healthcare · Radiology
Sep 2022
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K221932 is an FDA 510(k) clearance for the Omni Legend, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on September 2, 2022, 63 days after receiving the submission on July 1, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K221932 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2022
Decision Date September 02, 2022
Days to Decision 63 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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