Class Class II
GXR-Series Diagnostic X-Ray System (K242019)
Description
GXR-Series Diagnostic X-Ray System by DRGEM Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242019
Clearance Date2025-01-07
Clearance TypeTraditional
Product CodeKPR
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242019
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. GXR-Series Diagnostic X-Ray System (K242019) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2020 |
Trace the full predicate network for K242019
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.