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)

DHX-70H, XTG-70H

K-Number: K221587 · 2023-03-03

ApplicantDigimed Co., Ltd.
Decision Date2023-03-03
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DHX-70H, XTG-70H is a medical device manufactured by Digimed Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under approval number K221587. 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 DHX-70H, XTG-70H?

DHX-70H, XTG-70H is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Digimed Co., Ltd.. The 510(k) number is K221587.

When was DHX-70H, XTG-70H approved by the FDA?

DHX-70H, XTG-70H received FDA 510(k) clearance on 2023-03-03, under approval number K221587.

What company makes DHX-70H, XTG-70H?

DHX-70H, XTG-70H is manufactured by Digimed Co., Ltd..

What is the FDA product code for DHX-70H, XTG-70H?

The FDA product code for DHX-70H, XTG-70H is EHD.

Other Devices by Digimed Co., Ltd.

K181891Portable X-ray System (Model: MiniX-V, Mini X-S) K220579Hybrid C70 K220574HYBRID S70

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.

↑