ClearRead CT Console - ClearRead CT Console - Riverain Technologies, Inc.

Duns Number:172223922

Device Description: ClearRead CT Console

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ClearRead CT Console

Version/Model Number

1.0.1.32

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 07, 2019

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

4b106f23-5054-4edf-b49a-8005ddbd7813

Public Version Date

May 11, 2022

Public Version Number

4

DI Record Publish Date

May 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RIVERAIN TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 221