| Primary Device ID | 06970569090573 |
| NIH Device Record Key | bbe95e8e-1acd-4797-ac26-6d1cafb27edb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digital Wireless Intraoral X-Ray Sensor |
| Version Model Number | Pluto0002XW |
| Catalog Number | / |
| 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 | 06970569090573 [Primary] |
| MUH | System, X-Ray, Extraoral Source, Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
| 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 |
| 06970569090573 - Digital Wireless Intraoral X-Ray Sensor | 2024-03-08The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric. |
| 06970569090573 - Digital Wireless Intraoral X-Ray Sensor | 2024-03-08 The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) is used in conjunction with dental Radiography in medical units. The p |
| 06970569090603 - Wireless Digital Flat Panel Detector | 2024-03-08 Mars1717X(Configuration:Mars1717X-PI) wireless digital flat panel detector is indicated for digital imaging solutions designed |
| 06970569090580 - Digital Intraoral X-ray Imaging System | 2023-12-29 The Digital Intra-Oral X-Ray Imaging System (Pluto0000X) is used in conjunction with dental Radiography in medical units. The pr |
| 06970569090597 - Digital Intraoral X-ray Imaging System | 2023-12-29 The Digital Intra-Oral X-Ray Imaging System (Pluto0015X) is used in conjunction with dental Radiography in medical units. The pr |
| 06970569090481 - Wireless Digital Flat Panel Detector | 2023-05-08 Mars1417V-TSI(Configuration:Mars1417V3-PI) Wireless Digital Flat Panel Detector |
| 06970569090559 - Digital Intraoral X-Ray Sensor | 2023-05-04 The CS 6200 is a USB-driven digital intraoral X-ray sensor based on CMOS technology that is specially designed for acquiring rea |
| 06970569090511 - Wireless Digital Flat Panel Detector | 2023-03-20 Mano4336W Wireless Digital Flat Panel Detector |