Cleared Traditional

Embrace Neonatal MRI System

K170978 · Aspect Imaging, Ltd. · Radiology
Jul 2017
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K170978 is an FDA 510(k) clearance for the Embrace Neonatal MRI System, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Aspect Imaging, Ltd. (Industrial Area Hevel Modi?In., IL). The FDA issued a Cleared decision on July 19, 2017, 107 days after receiving the submission on April 3, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K170978 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2017
Decision Date July 19, 2017
Days to Decision 107 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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