Class Class II
AVIEW Lung Nodule CAD (K221592)
Description
AVIEW Lung Nodule CAD by Coreline Soft Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221592
Clearance Date2023-02-24
Clearance TypeTraditional
Product CodeOEB
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221592
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. AVIEW Lung Nodule CAD (K221592) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021 |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co.,... | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242919 | V5med Lung AI | V5med, Inc. | 2025 |
Trace the full predicate network for K221592
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.