| Primary Device ID | 06970569090313 |
| NIH Device Record Key | 5797b480-7a1e-49a7-a22b-3d9b9ee5fbb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wireless Digital Flat Panel Detector |
| Version Model Number | Mars1717XF-CSI |
| Company DUNS | 421363780 |
| Company Name | iRay Technology Co. Ltd. |
| 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 | true |
| 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 | 06970569090313 [Primary] |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-08 |
| Device Publish Date | 2021-08-31 |
| 06970569090894 - Digital Intraoral X-ray Imaging System | 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 0) is used in conjunction with dental Radiography in medical units |
| 06970569090900 - Digital Intraoral X-ray Imaging System | 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 1) is used in conjunction with dental Radiography in medical units |
| 06970569090917 - Digital Intraoral X-ray Imaging System | 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 1.5) is used in conjunction with dental Radiography in medical uni |
| 06970569090924 - Digital Intraoral X-ray Imaging System | 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 2) is used in conjunction with dental Radiography in medical units |
| 06970569090610 - Wireless Digital Flat Panel Detector | 2024-10-25 Luna1012X (configuration: Luna1012X-G) Wireless Digital Flat Panel Detector |
| 06970569090870 - Wireless Digital Flat Panel Detector(19 pin) | 2024-10-24 Mars1717X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general r |
| 06970569090887 - Wireless Digital Flat Panel Detector(19 pin) | 2024-10-24 Mars1417X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general ra |
| 06970569090566 - Wireless Digital Flat Panel Detector | 2024-03-08 Mars1417X(Configuration:Mars1417X-PI) wireless digital flat panel detector is indicated for digital imaging solutions designed t |