510(k) Report

Devices descending from K083421

4 later devices reach MR-Touch Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+1K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+2K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+2K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—