510(k) Report

Devices descending from K091918

4 later devices reach Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)Gemss Healthcare CO., LTD.20230—
+1K211780ZEN-2090 TurboGenoray Co., Ltd.20220—
+1K181943OSCAR (OSCAR Prime, OSCAR Classic)Genoray Co., Ltd.20181—
+2K252229Belliger AceGenoray Co., Ltd.20260—