| Primary Device ID | B332VIAP0100 |
| NIH Device Record Key | e22d7bc7-a981-425c-b745-2f336a92e2ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Autoplaque for ORS Visual |
| Version Model Number | ORS-VISU-AP01 |
| Company DUNS | 240758818 |
| Company Name | Object Research Systems (ORS) Inc |
| 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 | 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 |
| B332VIAP0100 - Autoplaque for ORS Visual | 2018-09-24Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcified plaque lesions in c |
| B332VIAP0100 - Autoplaque for ORS Visual | 2018-09-24 Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcifi |
| B332VISU0105 - ORS Visual | 2018-09-24 ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the dis |
| B332VIVA0100 - Vessel Analysis for ORS Visual | 2018-09-24 Vessel Analysis is a post-processing add-on module for ORS Visual that enables radiologists, cardiologists, vascular surgeons, a |