ClearRead CT Console

GUDID M722Z19077V190530

ClearRead CT Console

Riverain Technologies, LLC

Radiology picture archiving and communication system application software

• Primary Device ID: M722Z19077V190530
• NIH Device Record Key: 502095b2-6b02-46c2-bc83-7920a5965d40
• Commercial Distribution Discontinuation: 2019-05-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ClearRead CT Console
• Version Model Number: 1.0.0.26
• 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	M722Z19077V190530 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-04-11

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