Class Class II
InferRead Lung CT.AI (K240554)
Description
InferRead Lung CT.AI by Infervision Medical Technology Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240554
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeOEB
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240554
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. InferRead Lung CT.AI (K240554) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221612 | ClearRead CT | Riverain Technologies, Inc. | 2022 |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co.,... | 2020 |
| K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017 |
Trace the full predicate network for K240554
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.