MAMMOMAT B.brilliant
GUDID 04056869987187
Siemens Healthcare GmbH
Stationary mammographic x-ray system, digital| Primary Device ID | 04056869987187 |
| NIH Device Record Key | e4edb33a-db88-4cf6-8570-c3e6199b7e57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAMMOMAT B.brilliant |
| Version Model Number | 11372950 |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869987187 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233539
FDA Product Code
| MUE | Full field digital, system, x-ray, mammographic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2024-04-20 |
Devices Manufactured by Siemens Healthcare GmbH
| 04056869985558 - MAGNETOM Viato.Mobile | 2024-07-01 |
| 04056869962801 - SOMATOM Pro.Pulse | 2024-06-18 |
| 04068151001075 - Syngo Carbon Enterprise Access | 2024-06-11 |
| 04056869279619 - CIARTIC Move | 2024-05-09 |
| 04056869987187 - MAMMOMAT B.brilliant | 2024-04-29 |
| 04056869987187 - MAMMOMAT B.brilliant | 2024-04-29 |
| 04056869996172 - AI-Rad Companion (Pulmonary) | 2024-04-15 |
| 04056869964331 - AI-Rad Companion (Pulmonary) | 2024-04-09 |
| 04056869961491 - MAGNETOM Terra.X | 2024-04-03 |
Trademark Results [MAMMOMAT B.brilliant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOMAT B.BRILLIANT 79366176 not registered Live/Pending |
Siemens Healthcare GmbH 2023-02-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.