Cleared Traditional

MRI PATIENT POSITIONING DEVICES

K093738 · Medtec, Inc. · Radiology
May 2010
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K093738 is an FDA 510(k) clearance for the MRI PATIENT POSITIONING DEVICES, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Medtec, Inc. (Kalona, US). The FDA issued a Cleared decision on May 14, 2010, 161 days after receiving the submission on December 4, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K093738 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2009
Decision Date May 14, 2010
Days to Decision 161 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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