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Carestream Health

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories3
Latest FDA decision2026-03-11
TypeNumberDevice NameCodeDateActions
510(k) K253185 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL2026-03-11 View
510(k) K250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorKPR2026-01-20 View
510(k) K213568 DRX-Rise Mobile X-ray SystemIZL2022-03-23 View
510(k) K203159 Lux 35 DetectorMQB2020-12-02 View
510(k) K163157 SmartGridMQB2017-03-21 View
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