| Primary Device ID | 00860290000346 |
| NIH Device Record Key | 5f8c50b6-1b1e-49ec-bc6a-892b8a7a8cca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | xCAT XL |
| Version Model Number | 11010 |
| Company DUNS | 079255809 |
| Company Name | XORAN TECHNOLOGIES LLC |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860290000346 [Primary] |
| IZL | System, X-Ray, Mobile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-10 |
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| 00860008443748 - MiniCAT 2D | 2024-02-06 |
| 00860008443717 - Xoran Workstation | 2024-01-26 Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation softwar |
| 00860008443724 - MiniCAT 2D | 2023-08-03 The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for us |
| 00860290000384 - XoranConnect | 2022-08-23 |
| 00860290000391 - Xoran Workstation | 2021-06-24 Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation softwar |
| 00860290000377 - MiniCAT 2D | 2020-12-22 The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for us |