Class Class II
REMEX Xcam6 (K250597)
Description
REMEX Xcam6 by Remedi, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250597
Clearance Date2025-07-31
Clearance TypeTraditional
Product CodeIZL
Regulation Number892.1720
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250597
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. REMEX Xcam6 (K250597) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182207 | TR90BH | Minxray, Inc. | 2018 |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray R... | Pixxgen Corporation | 2018 |
Trace the full predicate network for K250597
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.