| Primary Device ID | 00852491008023 |
| NIH Device Record Key | a81de5fc-71ec-4706-94c7-db187cf585d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chest-CAD |
| Version Model Number | 1.0.0 |
| Company DUNS | 042356781 |
| Company Name | Imagen Technologies, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852491008023 [Primary] |
| MYN | Analyzer, Medical Image |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-03 |
| Device Publish Date | 2021-07-26 |
| 00852491008030 - Aorta-CAD | 2023-04-14 Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions |
| 00852491008023 - Chest-CAD | 2021-08-03Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016 |
| 00852491008023 - Chest-CAD | 2021-08-03 Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD |
| 00852491008016 - FractureDetect (FX) | 2021-04-20 FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fract |