Cleared Traditional

K932344 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES (FDA 510(k) Clearance)

Oct 1993
Decision
164d
Days
Class 2
Risk

K932344 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 October 25, 1993, 164 days after receiving the submission on May 14, 1993.

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

Submission Details

510(k) Number K932344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1993
Decision Date October 25, 1993
Days to Decision 164 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

Similar Devices — LNH System, Nuclear Magnetic Resonance Imaging

All 76
Magnifico Open (100009900)
K251901 · Esaote, S.P.A. · Mar 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
K253648 · Philips Medical Systems Nederland B.V. · Feb 2026
SIGNA™ Bolt
K253780 · Ge Medical Systems, LLC · Feb 2026
SIGNA™ Sprint Select
K253779 · Ge Medical Systems, LLC · Feb 2026
AIR Recon DL
K252379 · Ge Medical Systems, LLC · Dec 2025
MAGNETOM Sola
K252838 · Siemens Healthcare GmbH · Dec 2025