FDA 510(k) Applications Submitted by iRay Technology Taicang Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K220422 02/14/2022 Dental sensors NanoPix1, NanoPix2 iRay Technology Taicang Ltd.
K220536 02/24/2022 Digital flat panel detector iRay Technology Taicang Ltd.
K221714 06/13/2022 Flat Panel Detector iRay Technology Taicang Ltd.
K212279 07/20/2021 Digital Intraoral X-ray Imaging System iRay Technology Taicang Ltd.
K220668 03/07/2022 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K201043 04/20/2020 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) iRay Technology Taicang Ltd.
K221345 05/09/2022 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K222886 09/23/2022 Mercu 1717V iRay Technology Taicang Ltd.
K213529 11/04/2021 Focus HD 43 Detector iRay Technology Taicang Ltd.
K213646 11/04/2021 Focus HD 35 Detector iRay Technology Taicang Ltd.
K210314 02/03/2021 Mars1717X Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K210316 02/03/2021 Mars 1417X Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K200622 03/09/2020 Focus 43C detector, TRIMAX 43C detector iRay Technology Taicang Ltd.
K201004 04/16/2020 Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W iRay Technology Taicang Ltd.
K192512 09/12/2019 Focus 35C Detector, Trimax 35C Detector iRay Technology Taicang Ltd.
K182550 09/17/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K182551 09/17/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K183422 12/10/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd.
K183713 12/10/2018 Wireless Digital Flat Detector iRay Technology Taicang Ltd.
K210312 02/03/2021 PlutoX Digital Intraoral X-Ray Imaging System iRay Technology Taicang Ltd.
K223010 09/29/2022 Portable X-ray System iRay Technology Taicang Ltd.


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