SOMATOM X.cite

GUDID 04056869295541

Siemens Shanghai Medical Equipment Ltd.

Full-body CT system

• Primary Device ID: 04056869295541
• NIH Device Record Key: c8119f2e-a4ba-4b03-8516-69f88c4fa0d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMATOM X.cite
• Version Model Number: 11501200
• Company DUNS: 654129626
• Company Name: Siemens Shanghai Medical Equipment Ltd.
• 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
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869295541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191891

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2025-12-08
• Device Publish Date: 2025-11-30

Devices Manufactured by Siemens Shanghai Medical Equipment Ltd.

• 04056869295541 - SOMATOM X.cite: 2025-12-08
• 04056869295541 - SOMATOM X.cite: 2025-12-08
• 04056869295558 - SOMATOM X.ceed: 2025-12-08
• 04056869973500 - SOMATOM Pro.Pulse: 2025-12-08
• 04056869267180 - CIOS SELECT: 2023-06-16
• 04056869267197 - CIOS SELECT: 2023-06-15 mobile C-arm; software version VA21
• 04056869951386 - MULTIX Impact E: 2022-10-04
• 04056869279985 - MULTIX Impact: 2021-11-18
• 04056869262147 - MULTIX Impact C: 2021-03-30