| Primary Device ID | M722X25122P250640 |
| NIH Device Record Key | fa3d7f7f-84d9-4c20-afa5-76aaff924004 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearRead Xray Pneumothorax |
| Version Model Number | 2.0.0 |
| 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 | M722X25122P250640 [Primary] |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-25 |
| Device Publish Date | 2025-06-17 |
| M722XD25064P250640 | ClearRead Xray Docker Pneumothorax |
| M722XC25064P250640 | ClearRead Xray Console Pneumothorax |
| M722X25064P250640 | ClearRead Xray Server Pneumothorax |
| M722XD25114P250640 | ClearRead Xray Docker Pneumothorax |
| M722XC25114P250640 | ClearRead Xray Console Pneumothorax |
| M722X25122P250640 | ClearRead Xray Server Pneumothorax |