| Primary Device ID | 06970569091006 |
| NIH Device Record Key | 9f12a251-2462-4358-9a3d-b15376ccc630 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) |
| Version Model Number | RiasDR |
| Company DUNS | 421363780 |
| Company Name | iRay Group |
| 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 | 06970569091006 [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 | 2025-09-03 |
| Device Publish Date | 2025-08-26 |
| 06970569090993 - iRay | 2026-01-21 The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature dat |
| 06970569090856 - Digital Intraoral X-ray Imaging System | 2025-09-08 The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used |
| 06970569090863 - Digital Intraoral X-ray Imaging System | 2025-09-08 The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used |
| 06970569091006 - Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | 2025-09-03Digital Radiographic Imaging Acquisition Software - DR (RiasDR) |
| 06970569091006 - Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | 2025-09-03 Digital Radiographic Imaging Acquisition Software - DR (RiasDR) |
| 06970569091020 - Wireless Digital Flat Panel Detector | 2025-06-19 DR10FW Wireless Digital Flat Panel Detector_LTF |
| 06970569090931 - Mano4336A Wireless Digital Flat Panel Detector | 2025-05-21 Mano4336A clearance depends on Mars1417X by LTF |
| 06970569090948 - Mano4336F Wireless Digital Flat Panel Detector | 2025-05-21 Mano4336F clearance depends on Mars1417X by LTF |
| 06970569090955 - Mano4343A Wireless Digital Flat Panel Detector | 2025-05-21 Mano4336A clearance depends on Mars1717X by LTF |