| Primary Device ID | E247G86000 |
| NIH Device Record Key | b3fd5954-27fe-437e-82d0-a5447c25630c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ScanX Intraoral View |
| Version Model Number | G8600 |
| Company DUNS | 315563684 |
| Company Name | DÜRR DENTAL SE |
| 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 |
|---|---|
| HIBCC | E247G86000 [Primary] |
| MUH | System, X-Ray, Extraoral Source, Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-08-23 |
| Device Publish Date | 2018-07-06 |
| E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 0 | 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners). |
| E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 2 | 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners). |
| E247G8800 - ScanX Swift 2.0 | 2023-03-07 Dental Image Plate Scanner |
| E247G8900 - ScanX Swift View 2.0 | 2023-03-07 Dental Image Plate Scanner |
| E247E7300A10 - VisionX | 2022-04-04 VisionX version 3.0.x |
| E247A78610 - ProVecta 3D Prime Ceph | 2022-03-14 X-Ray System |
| E247J21101 - CamX Elara | 2022-03-14 |
| E247J27111 - CamX Cam Interchangeable Head | 2022-03-14 |