FDA 510(k) Applications Submitted by Gina Maiolo

FDA 510(k) Number Submission Date Device Name Applicant
K191025 04/18/2019 DRX-Revolution Mobile X-ray System Carestream Health Inc.
K213307 10/04/2021 Eclipse II with Smart Noise Cancellation Carestream Health, Inc.
K203159 10/23/2020 Lux 35 Detector Carestream Health
K213568 11/09/2021 DRX-Rise Mobile X-ray System Carestream Health
K183245 11/21/2018 Carestream DRX-1 System with DRX Plus 2530 Detectors Carestream Health, Inc.


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