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Carestream Health, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories5
Latest FDA decision2025-09-04
TypeNumberDevice NameCodeDateActions
510(k) K251168 Image SuiteLLZ2025-09-04 View
510(k) K241505 DRX-Revolution Mobile X-ray SystemIZL2024-12-10 View
510(k) K233381 DRX-Evolution Plus SystemKPR2024-03-12 View
510(k) K223842 DRX - CompassKPR2023-01-20 View
510(k) K213307 Eclipse II with Smart Noise CancellationMQB2022-01-14 View
510(k) K202441 Eclipse II with Smart Noise CancellationMQB2021-04-02 View
510(k) K201373 DRX-CompassKPR2020-06-26 View
510(k) K192894 Vita Flex CR System with LLIMQB2020-02-18 View
510(k) K193574 Q-Rad SystemKPR2020-01-22 View
510(k) K191879 DRX-Evolution with Carestream Digital TomosynthesisKPR2019-12-20 View
510(k) K190330 DRX-Evolution/Plus with Dual EnergyKPR2019-11-04 View
510(k) K191025 DRX-Revolution Mobile X-ray SystemIZL2019-05-17 View
510(k) K183245 Carestream DRX-1 System with DRX Plus 2530 DetectorsMQB2019-02-08 View
510(k) K183474 Carestream DRX-1 System with DRX Core DetectorsMQB2019-01-16 View
510(k) K180809 Eclipse IIMQB2018-06-21 View
510(k) K180667 SmartGridMQB2018-04-13 View
510(k) K173924 DRX-Revolution Nano Mobile X-ray SystemIZL2018-02-05 View
510(k) K173478 OnSight 3D Extremity SystemJAK2018-01-19 View
510(k) K170755 DRX-Revolution Nano Mobile X-ray SystemIZL2017-06-21 View
510(k) K170580 Carestream Vue PACSLLZ2017-04-11 View

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