syngo.MR Applications

GUDID 04056869981888

Siemens Healthcare GmbH

Radiology DICOM image processing application software

• Primary Device ID: 04056869981888
• NIH Device Record Key: 777ac709-910d-454f-b866-6f6769f5e735
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: syngo.MR Applications
• Version Model Number: 11583169
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869981888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253495

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: 2025-12-03
• Device Publish Date: 2025-11-25

On-Brand Devices [syngo.MR Applications]

• 04056869163185: 11344736
• 04056869230214: 11410391
• 04056869296210: 11583169
• 04056869953014: 11665248
• 04056869981888: 11583169