| Primary Device ID | B332VISU0105 |
| NIH Device Record Key | 9a1c17cf-b51b-483c-b933-44c5a671c546 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORS Visual |
| Version Model Number | ORS-VISU-0105 |
| 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 |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com | |
| Phone | 514-843-3861 |
| info@theobjects.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B332VISU0105 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2016-09-15 |
| 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 | 2018-09-24ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualizat |
| 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 |