FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455)
Description
FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) by Fluoptics Sas (A Getinge Group Company}, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250455
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. FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imagi... | Fluoptics Sas (A Getinge Group Comp... | 2023 |
| K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | 2022 |
Trace the full predicate network for K250455
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.