| 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 |
| E24721301004130 - VistaPosition Anterior | 2024-05-27 |
| E24721301004140 - VistaPosition Posterior | 2024-05-27 |
| E24721301004150 - VistaPosition Endo | 2024-05-27 |
| E24721301004160 - VistaPosition Bitewing | 2024-05-27 |
| E247G37101 - VistaPosition Anterior/ Posterior Kit Titanium | 2024-05-27 |
| E247G38101 - VistaPosition Anterior/ Posterior Kit | 2024-05-27 |
| 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). |