Cleared Traditional

StarGuide

K210173 · Ge Healthcare · Radiology
Mar 2021
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K210173 is an FDA 510(k) clearance for the StarGuide, 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 March 29, 2021, 66 days after receiving the submission on January 22, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K210173 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2021
Decision Date March 29, 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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