Cleared Traditional

K920094 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES (FDA 510(k) Clearance)

May 1992
Decision
128d
Days
Class 2
Risk

K920094 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on May 15, 1992, 128 days after receiving the submission on January 8, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K920094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date May 15, 1992
Days to Decision 128 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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