MAMMOVISTA B.smart

GUDID 04056869299297

Medical software that provides workflow, reading and reporting support on clinical images

Siemens Healthcare GmbH

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 04056869299297
• NIH Device Record Key: 8a8d629c-3ef4-4f79-bce9-e92ceefaf9c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAMMOVISTA B.smart
• Version Model Number: VB7
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869299297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223363

FDA Product Code

• LLZ: System, image processing, radiological

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: 2026-01-26
• Device Publish Date: 2026-01-16

On-Brand Devices [MAMMOVISTA B.smart]

• 04056869955575: 10400002
• 04056869281230: 10400002
• 04056869299297: Medical software that provides workflow, reading and reporting support on clinical images