Lung-CAD
Imagen Technologies, Inc.
IMAGEN TECHNOLOGIES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014661828 | 3014661828 | IMAGEN TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 420 Lexington Avenue Suite 300, Office 365 New York NY US 10170 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 219956 | 1446686230 | K230085 | Lung-CAD | MYN | 2023-10-03 |
| 219956 | 1994182007 | K223811 | Lung-CAD | MYN | 2023-09-13 |
| 219956 | 1176139805 | K213353 | Aorta-CAD | MYN | 2022-09-20 |
| 219956 | 1256959254 | K210666 | Chest-CAD | MYN | 2021-07-20 |
| 219956 | 1059458917 | K193417 | FractureDetect (FX) | QBS | 2020-07-30 |
Product Codes Associated With Registrations#
PMN#
Lung-CAD
Imagen Technologies, Inc.
Aorta-CAD
Imagen Technologies, Inc.
FractureDetect (FX)
Imagen Technologies, Inc.
GUDID#
ChestSuite - ChestSuite is a software bundle that aggregates the functionalities and outputs of three FDA clearances: Aorta-CAD (AC) and Lung-CAD (LC), and Lung-CAD (LC). The indications for use are as follows: AC is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta. AC is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. AC is indicated for adults only. LC is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for lung hyperinflation. The device uses a deep learning algorithm to identify ROIs with lung hyperinflation and produces boxes around the ROIs. LC is intended for use as a concurrent reading aid for physicians interpreting chest X-rays. The device is not intended for clinical diagnosis of any disease. It does not replace the role of the physician or of other diagnostic testing in the standard of care for lung parenchymal findings. LC is indicated for adults only.LC is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for interstitial thickening. The device uses a deep learning algorithm to identify ROIs with interstitial thickening and produces boxes around the ROIs. LC is intended for use as a concurrent reading aid for physicians interpreting chest X-rays. The device is not intended for clinical diagnosis of any disease. It does not replace the role of the physician or of other diagnostic testing in the standard of care for lung parenchymal findings. Lung-CAD is indicated for adults only.
2026-04-15
Aorta-CAD - Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta.Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.
2023-04-06
Chest-CAD - Chest-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
2021-07-26
FractureDetect (FX) - FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
2021-04-12