| Primary Device ID | 08809278790345 |
| NIH Device Record Key | 3d07d54f-7816-4f6e-b2a2-cda573dc008c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFINITT RT Mobile |
| Version Model Number | INFINITT RT Mobile |
| Company DUNS | 688319156 |
| Company Name | INFINITT Healthcare Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 08809278790345 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-02 |
| Device Publish Date | 2022-08-25 |
| 08809278790000 - STARPACS | 2023-10-18 |
| 08809278790062 - INFINITT Cardiology PACS | 2023-10-18 |
| 08809278790079 - Xelis | 2023-10-18 |
| 08809278790086 - Xelis 3D | 2023-10-18 |
| 08809278790093 - Xelis Fusion | 2023-10-18 |
| 08809278790109 - Xelis Cardiac | 2023-10-18 |
| 08809278790116 - Xelis Dental | 2023-10-18 |
| 08809278790123 - INFINITT ULite | 2023-10-18 |