| K-number | K251203 |
| Device name | AVIEW Lung Nodule CAD |
| Applicant | Coreline Soft Co., Ltd. |
| Product code | OEB |
| Device class | Class II |
| Decision date | Dec 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
AVIEW Lung Nodule CAD is computer-aided detection software that assists radiologists in identifying pulmonary nodules 3–20 mm in diameter during chest CT review of asymptomatic populations. The software uses deep convolutional neural networks to automatically detect lung nodules and can function as a second reader; it has been validated on non-contrast CT images, primarily from Siemens SOMATOM scanners.
The device uses the same technological characteristics (materials, energy source, control mechanisms) as the predicate device. Changes include cosmetic software UI modifications, updated installation/execution file icons, and a modified software operation environment. The core algorithm, intended use, and indications for use remain unchanged from the predicate.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov