| Primary Device ID | M722C16022E160130 |
| NIH Device Record Key | 9febe7a6-1038-4b40-848a-2a04a87675ef |
| Commercial Distribution Discontinuation | 2016-03-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ClearRead Enhanced |
| Version Model Number | 2.1.0 |
| 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 | M722C16022E160130 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-05-11 |
| Device Publish Date | 2016-01-26 |
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