Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Portable X-ray System

K-Number: K223010 · 2023-01-17

ApplicantIray Technology Taicang , Ltd.
Decision Date2023-01-17
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable X-ray System is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2023-01-17 under approval number K223010. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable X-ray System?

Portable X-ray System is a medical device that received FDA 510(k) clearance on 2023-01-17. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K223010.

When was Portable X-ray System approved by the FDA?

Portable X-ray System received FDA 510(k) clearance on 2023-01-17, under approval number K223010.

What company makes Portable X-ray System?

Portable X-ray System is manufactured by Iray Technology Taicang , Ltd..

What is the FDA product code for Portable X-ray System?

The FDA product code for Portable X-ray System is EHD.

Related Clinical Trials

NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_RECRUITING NCT05673408 NIBP Validation Study RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING NCT04436068 Hyperfine Portable MRI in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging ACTIVE_NOT_RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED

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 K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

View all 21 devices →

Related Devices (Code: EHD)

K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd. K160458BI IMAGE-X EVOLUTIONRadiotecnologia Industrial S.A. DE C.V. K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex K170967Intraskan DC PlusSkanray Technologies Private Limited K163705EzRay Air WVATECH Co., Ltd. K163519RX DCCefla S.C.

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.

↑