510(k) Report

Devices descending from K180021

5 later devices reach Proton Positioing and Immobilization Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV20222—
+1K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerMedtec, Inc. Dba Civco Medical Solutions and Civco20211—
+2K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV20231—
+2K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV20220—
+3K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV20250—