510(k) Report

Devices descending from K052987

2 later devices reach Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081118Noras MR-BI320-PA 1.5TNoras Mri Products GmbH20080—
+1K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc.20070—