MAGNETOM Flow.Ace

GUDID 04056869996219

Siemens Shenzhen Magnetic Resonance Ltd.

Full-body MRI system, superconducting magnet

• Primary Device ID: 04056869996219
• NIH Device Record Key: db3bb8ea-6750-430b-85e2-ff1d1d08a3da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNETOM Flow.Ace
• Version Model Number: 11571248
• Company DUNS: 544891302
• Company Name: Siemens Shenzhen Magnetic Resonance Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869996219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250436

FDA Product Code

• LNI: System, nuclear magnetic resonance spectroscopic

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: 2025-07-15
• Device Publish Date: 2025-07-07

On-Brand Devices [MAGNETOM Flow.Ace]

• 04056869996219: 11571248
• 04056869996202: 11571247