| Primary Device ID | 04056869955575 | 
| NIH Device Record Key | 4c422684-c332-48fb-a8ac-129181ca23cf | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MAMMOVISTA B.smart | 
| Version Model Number | 10400002 | 
| 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 | 
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04056869955575 [Primary] | 
| LLZ | System, image processing, radiological | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-12-22 | 
| Device Publish Date | 2021-12-14 | 
| 04056869955575 | 10400002 | 
| 04056869281230 | 10400002 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MAMMOVISTA B.SMART  79317787  not registered Live/Pending | Siemens Healthcare GmbH 2021-06-18 |