Cleared Traditional

MaxFOV 2

K203617 · Ge Medical Systems, LLC · Radiology
Mar 2021
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K203617 is an FDA 510(k) clearance for the MaxFOV 2, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on March 2, 2021, 81 days after receiving the submission on December 11, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K203617 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2020
Decision Date March 02, 2021
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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