510(k) Report

Devices descending from P010025

5 later devices reach Lorad Digital Breast Imager through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162670RSM 1824C with RConsole1DRTECH Corporation20174—
+2K2029022430MCA with Xmaru WRayence Co., Ltd.20211—
+2K170930RSM 2430CDRTECH Corporation20171—
+3K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+3K241113Vivix-MVieworks Co., Ltd.20250—