Cleared Traditional

PET VCAR

K211247 · GE Medical Systems SCS · Radiology
Jul 2021
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K211247 is an FDA 510(k) clearance for the PET VCAR, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on July 27, 2021, 92 days after receiving the submission on April 26, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K211247 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2021
Decision Date July 27, 2021
Days to Decision 92 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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