Biograph Trinion.X EP9 CT128

GUDID 04068151048063

SIEMENS MEDICAL SOLUTIONS USA, INC.

PET/CT system

• Primary Device ID: 04068151048063
• NIH Device Record Key: 33c36be6-c945-46bb-b05b-f13fc2e3a094
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biograph Trinion.X EP9 CT128
• Version Model Number: 11713858
• Company DUNS: 868230876
• Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.
• 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
• 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	04068151048063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251561

FDA Product Code

• KPS: System, tomography, computed, emission

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: 2025-09-05
• Device Publish Date: 2025-08-28

Devices Manufactured by SIEMENS MEDICAL SOLUTIONS USA, INC.

• 04068151048063 - Biograph Trinion.X EP9 CT128: 2025-09-05
• 04068151048063 - Biograph Trinion.X EP9 CT128: 2025-09-05
• 04068151009460 - syngo.MI General: 2025-08-21
• 04068151009453 - syngo.MM Oncology: 2025-08-19
• 04056869281483 - AcuNav Crystal Ultrasound Catheter: 2025-01-13
• 04056869990415 - 11M2 Transducer: 2024-12-05
• 04068151010022 - HLX Transducer: 2024-12-05
• 04068151009477 - Scenium: 2024-09-16
• 04068151027013 - MI View&GO: 2024-09-16