ClearRead CT Console

GUDID M722Z19154V191210

ClearRead CT Console

Riverain Technologies, LLC

Radiology PACS software

• Primary Device ID: M722Z19154V191210
• NIH Device Record Key: e92f52b6-7c58-47b3-a72f-cf94c0ad05ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearRead CT Console
• Version Model Number: 1.0.2
• Company DUNS: 172223922
• Company Name: Riverain Technologies, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M722Z19154V191210 [Primary]

FDA Product Code

• OEB: Lung Computed Tomography System, Computer-Aided Detection

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: 2019-06-17
• Device Publish Date: 2019-06-07

On-Brand Devices [ClearRead CT Console]

• M722Z19077V190530: ClearRead CT Console
• M722Z19154V191210: ClearRead CT Console
• M722CC20133V201320: ClearRead CT Console
• M722CC20176V201320: ClearRead CT Console
• M722CC21133V211240: ClearRead CT Console
• M722CC21343V213240: ClearRead CT Console