510(k) Report

Devices descending from K082416

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134052Radiance 330 Proton Therapy SystemProtom International, Inc.20144—
+1K124002Verification ConsoleVarian Medical Systems20130—
+1K101294PT2 Varian Proton Therapy SystemVarian Medical Systems, Oncology Systems201010—
+2K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation20192—
+2K160063McLaren Proton Therapy SystemMclaren Health Care Corporation20160—
+2K133191Probeam Proton Therapy SystemVarian Medical Systems201431
+2K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems2012512
+3K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd.20231—
+3K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc.20222—
+3K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems201725
+3K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.201647
+4K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.20260—
+4K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20251—
+4K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.20250—
+4K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc.20231—
+4K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A.2017011
+5K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20260—