510(k) Report

Devices descending from K112112

4 later devices reach Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213735dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips)20222—
+1K213727dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips)20221—
+2K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…Philips Medical Systems Nederland B.V.20260—
+2K23334816 Breast CoilPhilips Medical System Nederlands B.V.20230—