| Primary Device ID | M722CC23282V232790 |
| NIH Device Record Key | 235f3793-58f3-4cdf-bf0e-f963a8b7cf6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearRead CT Console |
| Version Model Number | 5.8.0 |
| Company DUNS | 172223922 |
| Company Name | Riverain Technologies, Inc. |
| 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 | M722CC23282V232790 [Primary] |
| OEB | Lung Computed Tomography System, Computer-Aided Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
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| M722CC22311V213240 | ClearRead CT Console |
| M722CC22276V213240 | ClearRead CT Console |
| M722CC23171V231710 | ClearRead CT Console |
| M722CC23005V213240 | ClearRead CT Console |
| M722CC22347V213240 | ClearRead CT Console |
| M722CC23282V232790 | ClearRead CT Console |
| M722CC24025V240250 | ClearRead CT Console |
| M722CC24052V240250 | ClearRead CT Console |
| M722CC24239V242390 | ClearRead CT Console |
| M722CC24281V242810 | ClearRead CT Console |