Cleared Traditional

ADVANTAGE WORKSTATION PASTING 1.1

K031396 · GE Medical Systems · Radiology
May 2003
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K031396 is an FDA 510(k) clearance for the ADVANTAGE WORKSTATION PASTING 1.1, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on May 13, 2003, 11 days after receiving the submission on May 2, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K031396 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2003
Decision Date May 13, 2003
Days to Decision 11 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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