Cleared Traditional

INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H

K883649 · Instrumentarium Corp. · Radiology
Oct 1988
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K883649 is an FDA 510(k) clearance for the INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Instrumentarium Corp. (Washington D.C., US). The FDA issued a Cleared decision on October 19, 1988, 51 days after receiving the submission on August 29, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K883649 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1988
Decision Date October 19, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

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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