ASPECT IMAGING LTD

Address:27 Skaked St. Industrial Area Hevel Modi in,Shoham Tel Aviv,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Coil, Magnetic Resonance, Specialty (MOS) (2) System, Nuclear Magnetic Resonance Imaging (LNH) (2)

Premarket Exempt

Clear

WristView - 00858755006101 Catalog Number : 70006200

Device Description : The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume is an ellipsoid with dimensions of 120mm X 120 mm X 70mm around the magnet center. The overall dimensions of the magnet assembly are 140 cm x 100 cm x 235 cm [with patient trolley].

Device Class : 2

Duns Number: 533254041

Premarket Exempt : No

Product Code : MOS, LNH

Prescription Use : Yes

Device Count : 1

Embrace Neonatal MRI System - 00858755006309 Catalog Number : 70007000

Device Description : The Embrace Neonatal MRI System is indicated for use as a magnetic resonance ima 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.