Ashvins variant Ashvins Diagnostic Workstation

GUDID 04260648620084

MedicalCommunications GmbH

Radiology picture archiving and communication system workstation

• Primary Device ID: 04260648620084
• NIH Device Record Key: 1aa945ed-8725-4683-9024-d9fe11e9cc47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ashvins variant Ashvins Diagnostic Workstation
• Version Model Number: 2023 (Build 2088)
• Company DUNS: 314721366
• Company Name: MedicalCommunications 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260648620084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200132

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-07-17
• Device Publish Date: 2024-07-09

On-Brand Devices [Ashvins variant Ashvins Diagnostic Workstation]

• 04260648620084: 2023 (Build 2088)
• 04260648620077: 2023 (Build 2167)