510(k) Report

Devices descending from K082373

3 later devices reach Noras MR-BI320-PA 3T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162651Breast BI 7 MR Coil Mammavention 3TMoras Mri Products GmbH20172—
+2K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNoras Mri Products GmbH20220—
+2K180123Breast BI 7 MR Coil 1.5T MammaventionNoras Mri Products GmbH20181—