Embrace Neonatal MRI System
Aspect Imaging Ltd.
ASPECT IMAGING LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009714754 | 3009714754 | ASPECT IMAGING LTD | 1 | N | 2026-01-01 | 27 Skaked St. Industrial Area Hevel Modi"in Shoham Tel Aviv IL 6085001 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 155472 | 1262451478 | K170978 | Embrace Neonatal MRI System | LNH | 2017-07-19 |
| 155472 | 1763149859 | K160185 | Wrist 3 | LNH | 2016-03-01 |
| 155472 | 2028550289 | K130692 | M2 WRIST 2 MRI SYSTEM | LNH | 2014-01-14 |
| 155472 | 1745937935 | K120701 | M2 WRIST MRI SYSTEM | LNH | 2013-02-07 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LNH | 5 | 2017-07-19 |
PMN#
Wrist 3
ASPECT IMAGING LTD
M2 WRIST 2 MRI SYSTEM
ASPECT IMAGING LTD
M2 WRIST MRI SYSTEM
ASPECT IMAGING LTD
GUDID#
WristView - 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].
2016-08-15
Embrace Neonatal MRI System - 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.
2018-03-29