CAS-One IR Software 20016

GUDID 07616962000250

CAScination AG

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

• Primary Device ID: 07616962000250
• NIH Device Record Key: 85a5a7a2-32de-469e-92a2-a96616c42787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAS-One IR Software
• Version Model Number: 4.1
• Catalog Number: 20016
• Company DUNS: 485258433
• Company Name: CAScination AG
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07616962000250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232022

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: 2024-06-17
• Device Publish Date: 2024-06-07

Devices Manufactured by CAScination AG

• 17640167220028 - CAS-One IR Consumable Set General: 2024-06-25
• 07616962000250 - CAS-One IR Software: 2024-06-17
• 07616962000250 - CAS-One IR Software: 2024-06-17
• 07640167222414 - OTOPLAN: 2022-07-19
• 07640167222131 - CAS-One IR: 2022-06-21
• 07640167220724 - OTOPLAN: 2022-04-27