| Primary Device ID | 00858755006101 |
| NIH Device Record Key | 003cf016-4ee7-45c5-9108-9a0194de8ec9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WristView |
| Version Model Number | WristView |
| Catalog Number | 70006200 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00858755006101 [Primary] |
| MOS | Coil, Magnetic Resonance, Specialty |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-15 |
| 00858755006101 - WristView | 2018-07-06The 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]. |
| 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 | 2018-07-06 The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coron |