| Primary Device ID | B545032000000 |
| NIH Device Record Key | b99b869c-59ca-421b-9c69-82b42f1eaed7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MRopen 0.5 T |
| Version Model Number | 03-2000-00 |
| Company DUNS | 438236494 |
| Company Name | ASG SUPERCONDUCTORS SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | B545032000000 [Primary] |
| LNH | System, Nuclear Magnetic Resonance Imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-28 |
| Device Publish Date | 2019-05-20 |
| B54503200000120 - MRopen EVO | 2024-12-26 MROpen EVO 03-2000-00 v12 Whole body magnetic resonance diagnostic medical device intended for the production of images for diag |
| B5450320000080 - MRopen EVO | 2024-12-26 MROpen EVO 03-2000-00 v8 Whole body magnetic resonance diagnostic medical device intended for the production of images for diagn |
| B5450320000040 - MRopen EVO | 2023-12-25 |
| B545032000000 - MRopen 0.5 T | 2019-05-28 |
| B545032000000 - MRopen 0.5 T | 2019-05-28 |