Class Class II
INNOVISION-EXII (K242119)
Description
INNOVISION-EXII by Dk Medical System, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242119
Clearance Date2025-01-03
Clearance TypeTraditional
Product CodeKPR
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242119
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. INNOVISION-EXII (K242119) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | 2025 |
Trace the full predicate network for K242119
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.