Primary Device ID | M722X20320L203200 |
NIH Device Record Key | a7a4d537-7ceb-47a9-b2d8-a02255a7c19e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ClearRead Xray +Confirm |
Version Model Number | 3.0.0 |
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 Issuing Agency | Device ID |
---|---|
HIBCC | M722X20320L203200 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-11 |
Device Publish Date | 2021-02-03 |
M722C21343V213240 - ClearRead CT Server | 2022-02-07 ClearRead CT Server |
M722CC21343V213240 - ClearRead CT Console | 2022-02-07 ClearRead CT Console |
M722CD21343V213240 - ClearRead CT Docker | 2022-02-07 ClearRead CT Docker |
M722X21224B212210 - ClearRead Bone Suppress Server | 2021-09-01 ClearRead Bone Suppress on Server |
M722X21224C212210 - ClearRead Detect Server | 2021-09-01 ClearRead Detect on Server |
M722X21224E212210 - ClearRead Enhance Server | 2021-09-01 ClearRead Enhance on Server |
M722X21224L212210 - ClearRead Confirm Server | 2021-09-01 ClearRead Confirm on Server |
M722X21224T212210 - ClearRead Compare Server | 2021-09-01 ClearRead Compare on Server |