510(k) Report

Devices descending from K101508

6 later devices reach Modification to Iba Proton Therapy System-Proteus 235 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132919Gantry Beam LineIon Beam Applications S.A.201452
+2K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.201647
+3K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems201725
+3K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A.2017011
+4K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20251—
+5K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20260—