| Primary Device ID | B209CAR1X10 |
| NIH Device Record Key | c974fbbd-f029-45ff-a683-3ff903457ba6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V3D-Cardiac |
| Version Model Number | 1.1 |
| Company DUNS | 017608345 |
| Company Name | VIATRONIX INCORPORATED |
| 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 | true |
| 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 | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com | |
| Phone | (631) 771-1801 |
| csdsupport@viatronix.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B209CAR1X10 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2016-06-17 |
| B209CAR1X10 - V3D-Cardiac | 2018-09-24V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed t |
| B209CAR1X10 - V3D-Cardiac | 2018-09-24 V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human h |
| B209CAS2X00 - V3D-Calcium Scoring | 2018-09-24 V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is de |
| B209CAS2X10 - V3D-Calcium Scoring | 2018-09-24 V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is de |
| B209VA2X00 - V3D-Vascular | 2018-09-24 V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is d |
| B209VC3X3X3X10 - V3D-Colon | 2018-09-24 V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image |
| B209VC4X0X0X360 - V3D-Colon | 2018-09-24 V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image |
| B209VC4X0X0X44F0 - V3D-Colon | 2018-09-24 V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image |
| B209VC4X0X3X13F0 - V3D-Colon | 2018-09-24 V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image |