MAMMOMAT B.brilliant

GUDID 04056869987187

Siemens Healthcare GmbH

Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital 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

• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

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

• 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
• 04056869973135 - MAGNETOM Terra.X Upgrade: 2024-04-03
• 04056869975238 - MAGNETOM Cima.X Fit: 2024-03-13
• 04056869991269 - syngo Virtual Cockpit: 2024-01-24