Embrace Neonatal MRI System 70007000

GUDID 00858755006309

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.

ASPECT IMAGING LTD

Full-body MRI system, permanent magnet

• Primary Device ID: 00858755006309
• NIH Device Record Key: 383583f2-91a6-48d0-8df0-9befe92d0ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embrace Neonatal MRI System
• Version Model Number: Embrace
• Catalog Number: 70007000
• Company DUNS: 533254041
• Company Name: ASPECT IMAGING LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858755006309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170978

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-29

Devices Manufactured by ASPECT IMAGING LTD

• 00858755006101 - WristView: 2018-07-06 The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume
• 00858755006309 - Embrace Neonatal MRI System: 2018-07-06The 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.
• 00858755006309 - Embrace Neonatal MRI System: 2018-07-06 The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coron