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Embrace Neonatal MRI System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K170978

by Aspect Imaging, Ltd.

Identity

Trade Name
Embrace Neonatal MRI System FDA UDI
Generic Name
Full-body MRI system, permanent magnet FDA UDI
Device Name
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. FDA UDI
Model / Reference
Embrace FDA UDI
Description
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. FDA UDI

Identifiers

Catalog Number
70007000 FDA UDI
Primary DI / UDI-DI
00858755006309 FDA UDI
510(k) Number
K170978 FDA 510(k)FDA UDI
FDA Product Code
LNH FDA 510(k)FDA UDI
MOS FDA UDI
GMDN Term
Full-body MRI system, permanent magnet FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)FDA UDI
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Embrace Neonatal MRI System is a Nuclear Magnetic Resonance Imaging System designed for neonatal patients. It provides high-resolution imaging of the brain and body in critically ill infants, enabling detailed assessment of neurological and structural abnormalities in a compact, point-of-care format. This system is specifically engineered to support early diagnosis and monitoring of neonatal conditions within neonatal intensive care units (NICUs).

The system is supplied as a self-shielded, compact MRI unit with multiple coil configurations for neonatal imaging. It is intended for single-use or reusable applications in MRI-compatible environments, adhering to strict MRI safety standards. The device is FDA-cleared under 510K classification (K170978) and falls under Device Class II (OpenFDA: LNH, 892.1000). No information on sterility or storage conditions is provided in the specifications.

Frequently asked questions

What is the Embrace Neonatal MRI System designed for?

The Embrace Neonatal MRI System is specifically engineered for neonatal patients to provide high-resolution imaging of the brain and body. It supports early diagnosis and continuous monitoring of neurological and structural abnormalities in critically ill infants, particularly within neonatal intensive care units (NICUs). The compact, point-of-care design ensures accessibility for time-sensitive clinical assessments.

How is the Embrace Neonatal MRI System supplied, and what configurations are included?

The system is supplied as a self-shielded, compact MRI unit. It includes multiple coil configurations tailored for neonatal imaging, allowing flexibility for different clinical needs. The design prioritizes safety and ease of integration into MRI-compatible environments, ensuring compatibility with existing NICU workflows.

Is the Embrace Neonatal MRI System intended for single-use or reusable applications?

The device is designed for both single-use and reusable applications, depending on clinical protocols and facility preferences. The manufacturer emphasizes adherence to strict MRI safety standards, which may influence how the system is processed between uses. Facilities should consult the provided instructions for proper cleaning, disinfection, and maintenance procedures.

What safety standards does the Embrace Neonatal MRI System adhere to?

The Embrace Neonatal MRI System is engineered to comply with strict MRI safety standards, ensuring safe operation in clinical environments. Its self-shielded design reduces electromagnetic interference and minimizes risks to patients and staff. However, specific sterility or storage conditions are not detailed in the specifications, so facilities should follow established protocols for MRI equipment handling.

What regulatory approvals does the Embrace Neonatal MRI System hold?

The Embrace Neonatal MRI System holds FDA clearance under the 510K classification, with the clearance number K170978. It is classified as Device Class II under the OpenFDA system (LNH, 892.1000). The system was reviewed by the Radiology Advisory Committee and is intended for use in radiology settings, particularly for neonatal imaging.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Neonatal MRI System | NICU | Embrace MRI System, Neonatal MRI System | MRI Solutions - Aspect Imaging, MRI Solutions - Compact MRI Systems for Preclinical Imaging

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aspect Imaging, Ltd.

Sources (2)

  • FDA 510(k) K170978 24 fields · synced Oct 1, 2026
  • FDA UDI 383583f2-91a6-48d0-8df0-9befe92d0ab5 35 fields · synced May 27, 2026