Biograph Trinion.X EP5 CT64

GUDID 04068151048087

SIEMENS MEDICAL SOLUTIONS USA, INC.

PET/CT system

• Primary Device ID: 04068151048087
• NIH Device Record Key: c531bd4e-38b5-4074-b591-516fd358d03c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biograph Trinion.X EP5 CT64
• Version Model Number: 11713854
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04068151048087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251561

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: 2026-01-19
• Device Publish Date: 2026-01-09

Devices Manufactured by SIEMENS MEDICAL SOLUTIONS USA, INC.

• 04068151048056 - Biograph Trinion.X EP5 CT128: 2026-01-19
• 04068151048070 - Biograph Trinion.X EP9 CT64: 2026-01-19
• 04068151048087 - Biograph Trinion.X EP5 CT64: 2026-01-19
• 04068151048087 - Biograph Trinion.X EP5 CT64: 2026-01-19
• 04068151019858 - 10BCC3 Transducer: 2025-12-31
• 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