Embrace Neonatal MRI System— 510(k) K254277

Name: FDA 510(k) clearance K254277
Creator: U.S. Food and Drug Administration
Published: 2026-03-13

Substantially Equivalent

Aspect Imaging, Ltd.

FDA 510(k) clearance K254277 for Embrace Neonatal MRI System, Substantially Equivalent on 2026-03-13. Applicant: Aspect Imaging, Ltd.. Device class: 2.

Summary

Aspect Imaging's Embrace Neonatal MRI System is filed under LNH, nuclear magnetic resonance imaging systems. The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).

Aspect Imaging filed from Shoham, Israel. The decision came 73 calendar days after receipt (December 30, 2025 to March 13, 2026).

Clearance details

Applicant: Aspect Imaging, Ltd.
Product code: Product code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2025-12-30
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoham, IL

Download summary PDF View on FDA.gov ↗

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K261612 — SwiftSight-BodyComposition2026-10-01
K261283 — APERTO Lucent MRI System2026-09-16
K261758 — Embrace Vision Neonatal MRI System2026-09-16

More clearances from Aspect Imaging, Ltd.

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K170978 — Embrace Neonatal MRI System2017-07-19
K160185 — Wrist 32016-03-01
K130692 — M2 WRIST 2 MRI SYSTEM2014-01-14
K120701 — M2 WRIST MRI SYSTEM2013-02-07

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.