510(k) Report

Devices descending from K162651

2 later devices reach Breast BI 7 MR Coil Mammavention 3T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNoras Mri Products GmbH20220—
+1K180123Breast BI 7 MR Coil 1.5T MammaventionNoras Mri Products GmbH20181—