| Primary Device ID | 04056869274638 |
| NIH Device Record Key | 760e6d18-ee80-4b22-82e1-f12595567736 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ai-Rad Companion Prostate MR |
| Version Model Number | 11545289 |
| Company DUNS | 313217003 |
| Company Name | Siemens Healthcare GmbH |
| 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 | 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 |
|---|---|
| GS1 | 04056869274638 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-16 |
| Device Publish Date | 2021-08-06 |
| 04056869257952 | AI-Rad Companion Prostate MR About Box |
| 04056869274638 | AI-Rad Companion Prostate MR About Box |