| Primary Device ID | 04056869250144 |
| NIH Device Record Key | 2e41ea60-65c4-4c87-841e-e6dd1777e698 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | syngo Utrasound Breast Analysis |
| Version Model Number | 11507859 |
| Company DUNS | 804722783 |
| Company Name | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 04056869250144 [Primary] |
| LMD | System, digital image communications, 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 | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
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| 04056869950747 - 6C1 HD Transducer | 2024-05-16 |
| 04056869950754 - 18L6HD Transducer | 2024-05-16 |
| 04056869954240 - 18L6 Transducer | 2024-05-16 |