Cleared Traditional

Digital Expert Access with Remote Scanning

K232346 · Ge Healthcare · Radiology
Oct 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K232346 is an FDA 510(k) clearance for the Digital Expert Access with Remote Scanning, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Ge Healthcare (Chicago, US). The FDA issued a Cleared decision on October 27, 2023, 84 days after receiving the submission on August 4, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K232346 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2023
Decision Date October 27, 2023
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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