syngo.Breast Care

GUDID 04056869006871

Mammo Accessory

Siemens Healthcare GmbH

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 04056869006871
• NIH Device Record Key: 83aa67c7-3b2f-4a59-bb35-d7e57b6d44eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: syngo.Breast Care
• Version Model Number: 10590800
• 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: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869006871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123420

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [syngo.Breast Care]

• 04056869044651: 11105252
• 04056869006871: Mammo Accessory