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FDA 510(k)

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

K-Number: K201043 · 2020-05-12

ApplicantIray Technology Taicang , Ltd.
Decision Date2020-05-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2020-05-12 under approval number K201043. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is a medical device that received FDA 510(k) clearance on 2020-05-12. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K201043.

When was Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) approved by the FDA?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) received FDA 510(k) clearance on 2020-05-12, under approval number K201043.

What company makes Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is manufactured by Iray Technology Taicang , Ltd..

What is the FDA product code for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

The FDA product code for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is MQB.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41346994 The status quo of the development of decentralized clinical trials. Frontiers in medicine (2025) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

Other Devices by Iray Technology Taicang , Ltd.

K182550Wireless Digital Flat Panel Detector K182551Wireless Digital Flat Panel Detector K192512Focus 35C Detector, Trimax 35C Detector K183713Wireless Digital Flat Detector K183422Wireless Digital Flat Panel Detector K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

View all 21 devices →

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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