| Primary Device ID | 06975501940251 |
| NIH Device Record Key | 406abf0e-6df9-4e85-bfd8-85d9c88c009b |
| Commercial Distribution Discontinuation | 2023-02-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | iRay SmartP |
| Version Model Number | Canis014D07 |
| Company DUNS | 722762367 |
| Company Name | iRay Imaging Technology (Haining) Limited |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975501940251 [Primary] |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-02-28 |
| Device Publish Date | 2023-01-28 |
| 06975501940282 - iRay | 2024-07-29 |
| 06975501940251 - iRay SmartP | 2023-02-28Canis014D04 portable X-ray system (SmartP) |
| 06975501940251 - iRay SmartP | 2023-02-28 Canis014D04 portable X-ray system (SmartP) |
| 06975501940268 - iRay SmartV | 2023-02-28 Canis014D04V portable X-ray system (SmartV) |
| 06975501940008 - iRay | 2022-11-08 Cetus 32R01 High-Voltage Generator |
| 06975501940015 - iRay | 2022-11-08 Cetus 32F01 High-Voltage Generator |
| 06975501940022 - iRay | 2022-11-08 Cetus 40R01 High-Voltage Generator |
| 06975501940039 - iRay | 2022-11-08 Cetus 40F01 High-Voltage Generator |
| 06975501940046 - iRay | 2022-11-08 Cetus 50R01 High-Voltage Generator |