| Primary Device ID | 00850003095004 |
| NIH Device Record Key | 87b9f6e9-e775-4d29-931d-304db22c76fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InferRead Lung CT.AI 2.1.2.1 |
| Version Model Number | 2.1.2.1 |
| Company DUNS | 117164757 |
| Company Name | Infervision US 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003095004 [Primary] |
| OEB | Lung Computed Tomography System, Computer-Aided Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-31 |
| Device Publish Date | 2021-03-23 |
| 00850003095011 - InferRead CT Stroke.AI | 2021-08-26 InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced |
| 00850003095004 - InferRead Lung CT.AI 2.1.2.1 | 2021-03-31Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest. |
| 00850003095004 - InferRead Lung CT.AI 2.1.2.1 | 2021-03-31 Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examin |