RTx

GUDID B334RTX1P100

MIRADA MEDICAL LIMITED

Radiology picture archiving and communication system workstation

• Primary Device ID: B334RTX1P100
• NIH Device Record Key: 2500ac92-c3b3-41fe-aab8-44c3737c4395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTx
• Version Model Number: 1.10
• Company DUNS: 211100325
• Company Name: MIRADA MEDICAL LIMITED
• 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: true
• 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
HIBCC	B334RTX1P100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130393

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: 2024-11-06
• Device Publish Date: 2024-10-29

On-Brand Devices [RTx]

• B334RTX1P80: 1.8
• B334RTX1P60: 1.6
• B334RTX1P100: 1.10