ClearRead CT

GUDID M722T19347V193460

ClearRead CT

Riverain Technologies, LLC

Radiology PACS software
Primary Device IDM722T19347V193460
NIH Device Record Key4fbc4366-2446-45b0-99a7-4001468e60a6
Commercial Distribution Discontinuation2020-08-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameClearRead CT
Version Model Number3.5.1
Company DUNS172223922
Company NameRiverain Technologies, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCM722T19347V193460 [Primary]

FDA Product Code

OEBLung Computed Tomography System, Computer-Aided Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-08-07
Device Publish Date2019-12-20

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