Class Class II
EXTRON 3; EXTRON 5; EXTRON 7 (K250010)
Description
EXTRON 3; EXTRON 5; EXTRON 7 by DRTECH Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250010
Clearance Date2025-06-10
Clearance TypeTraditional
Product CodeOWB
Regulation Number892.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250010
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. EXTRON 3; EXTRON 5; EXTRON 7 (K250010) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230871 | EXTRON 5; EXTRON 7 | DRTECH Corporation | 2023 |
| K142708 | VERADIUS UNITY | Philips Medical Systems Nethrlands BV | 2014 |
| K122234 | OEC 9900 ELITE | Ge Healthcare Surgery GE Oec Medica... | 2012 |
Trace the full predicate network for K250010
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.