Biograph Trinion.X EP9 CT128

GUDID 04068151048063

SIEMENS MEDICAL SOLUTIONS USA, INC.

PET/CT system
Primary Device ID04068151048063
NIH Device Record Key33c36be6-c945-46bb-b05b-f13fc2e3a094
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiograph Trinion.X EP9 CT128
Version Model Number11713858
Company DUNS868230876
Company NameSIEMENS MEDICAL SOLUTIONS USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS104068151048063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, tomography, computed, emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-05
Device Publish Date2025-08-28

Devices Manufactured by SIEMENS MEDICAL SOLUTIONS USA, INC.

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