ClearRead CT Console

GUDID M722CC25211V252110

ClearRead CT Console

Riverain Technologies, Inc.

Radiological PACS software
Primary Device IDM722CC25211V252110
NIH Device Record Keyc9942a12-3e57-488e-a094-5cfe3b2ed330
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearRead CT Console
Version Model Number5.11
Company DUNS172223922
Company NameRiverain Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM722CC25211V252110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OEBLung Computed Tomography System, Computer-Aided Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-03
Device Publish Date2025-08-26

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