510(k) Report

Devices descending from K110729

5 later devices reach Aspire HD Full-Field Digital Mammography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121674Aspire HD Plus, Aspire HD-SFujifilm Medical System U.S.A., Inc.201242
+2K133972Aspire CristalleFujifilm Medical Systems U.S.A, Inc.201432
+3K173132ASPIRE CristalleFujifilm Medical Systems U.S.A, Inc.20172—
+4K212873Aspire CristalleFujifilm Corporation20221—
+5K243420HestiaGenoray Co., Ltd.20250—