Class Class II
Lunit INSIGHT DBT v1.1 (K242652)
Description
Lunit INSIGHT DBT v1.1 by Lunit, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242652
Clearance Date2024-10-04
Clearance TypeSpecial
Product CodeQDQ
Regulation Number892.2090
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242652
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. Lunit INSIGHT DBT v1.1 (K242652) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023 |
Trace the full predicate network for K242652
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.