| Primary Device ID | 19356870000021 |
| NIH Device Record Key | 13217e63-1028-4864-abb3-ae28d79df4af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CT LVAS |
| Version Model Number | 1.x |
| Company DUNS | 747517097 |
| Company Name | 4DMEDICAL LIMITED |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 19356870000021 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
| 19356870000021 - CT LVAS | 2024-06-28CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report. |
| 19356870000021 - CT LVAS | 2024-06-28 CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quanti |
| 19356870000014 - XV Lung Ventilation Analysis Software | 2021-01-26 The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images i |