AI-Rad Companion Organs RT

GUDID 04056869973371

Siemens Healthcare GmbH

Radiology DICOM image processing application software

• Primary Device ID: 04056869973371
• NIH Device Record Key: 8bfb4fda-406d-4f81-b1f1-ce0ef5b581b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AI-Rad Companion Organs RT
• Version Model Number: 11665508
• Company DUNS: 313217003
• Company Name: Siemens Healthcare GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869973371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232899

FDA Product Code

• QKB: Radiological image processing software for radiation therapy

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: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [AI-Rad Companion Organs RT]

• 04056869257969: AI-Rad Companion Organs RT About Box
• 04056869274645: Ai-Rad Companion Organs RT About Box
• 04056869955667: 11665278
• 04056869973371: 11665508