FDA 510(k) Applications Submitted by Duane Gutowski

FDA 510(k) Number Submission Date Device Name Applicant
K201373 05/26/2020 DRX-Compass Carestream Health, Inc
K191879 07/15/2019 DRX-Evolution with Carestream Digital Tomosynthesis Carestream Health, Inc.
K202441 08/26/2020 Eclipse II with Smart Noise Cancellation Carestream Health, Inc.
K192894 10/11/2019 Vita Flex CR System with LLI Carestream Health, Inc.


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