Cleared Traditional

Embrace Neonatal MRI System

K254277 · Aspect Imaging, Ltd. · Radiology
Mar 2026
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K254277 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. (Shoham, IL). The FDA issued a Cleared decision on March 13, 2026, 73 days after receiving the submission on December 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K254277 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2025
Decision Date March 13, 2026
Days to Decision 73 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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