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FDA 510(k) Applications Submitted by Gina L 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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