510(k) Report

Devices descending from K191025

5 later devices reach DRX-Revolution Mobile X-ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241505DRX-Revolution Mobile X-ray SystemCarestream Health, Inc.20241—
+1K222339uDR 380i ProShanghai United Imaging Healthcare Co., Ltd.20221—
+1K213568DRX-Rise Mobile X-ray SystemCarestream Health20220—
+2K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health20260—
+2K242515uDR 380i ProShanghai United Imaging Healthcare Co., Ltd.20240—