| Primary Device ID | 08800025300237 |
| NIH Device Record Key | 0a3b111c-bd56-41e8-9612-4e3bc1c8a54a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVIEW CAC |
| Version Model Number | 2.0 |
| Company DUNS | 689517146 |
| Company Name | CORELINE SOFT 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 | false |
| Manufacturing Date | false |
| 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 | 08800025300237 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-03 |
| Device Publish Date | 2024-04-25 |
| 08800025300237 - AVIEW CAC | 2024-05-03 |
| 08800025300237 - AVIEW CAC | 2024-05-03 |
| 08800025300152 - AVIEW | 2023-10-18 |
| 08800025300176 - AVIEW Lung Nodule CAD | 2023-03-13 |
| 08800025300145 - AVIEW RT ACS | 2022-12-08 |
| 08800025300022 - AVIEW Modeler | 2021-08-17 |
| 08800025300039 - AVIEW LCS | 2021-08-17 |
| 08800025300077 - AVIEW | 2021-08-17 |
| 08800025300084 - AVIEW LCS | 2021-08-17 |