Cleared Traditional

INSTRUMENTARIUM ULF MR IMAGING SYSTEM

K883621 · Instrumentarium Corp. · Radiology
Nov 1988
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K883621 is an FDA 510(k) clearance for the INSTRUMENTARIUM ULF MR IMAGING SYSTEM, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Instrumentarium Corp. (Washington, US). The FDA issued a Cleared decision on November 10, 1988, 77 days after receiving the submission on August 25, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K883621 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1988
Decision Date November 10, 1988
Days to Decision 77 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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