Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

Solid State X-ray Imager (flat Panel/digital Imager)

IRay Technology Taicang Ltd.

The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Wireless Digital Flat Panel Detector Model Name Mars1417v-tsi, Wireless Digital Flat Panel Detector Model Name Mano4336w.

Pre-market Notification Details

Device IDK201004
510k NumberK201004
Device Name:Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant iRay Technology Taicang Ltd. No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang,  CN 215434
ContactMeng Li
CorrespondentMeng Li
iRay Technology Taicang Ltd. No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang,  CN 215434
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-16
Decision Date2020-05-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06972093830151 K201004 000
06972093830144 K201004 000
06972093830151 K201004 000
06972093830144 K201004 000
06972093830151 K201004 000
06972093830144 K201004 000

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