Scenium

GUDID 04056869975559

SIEMENS MEDICAL SOLUTIONS USA, INC.

PET system application software

• Primary Device ID: 04056869975559
• NIH Device Record Key: f5362914-824e-49e6-aa3f-6360c1b431ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scenium
• Version Model Number: 11431591
• 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: false
• 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
• 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	04056869975559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232000

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2023-12-15
• Device Publish Date: 2023-12-07

On-Brand Devices [Scenium]

• 04056869147925: 11298565
• 04056869041087: 10909201
• 04056869002156: 10764040
• 04056869243405: 11431532
• 04056869975559: 11431591
• 04056869950198: 11431562
• 04068151009477: 11589501