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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 the device name listed in this FDA 510(k) record. The listed applicant is Digimed Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) 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. The listed applicant is Digimed Co., Ltd.. The 510(k) number is K221587.

When did DHX-70H, XTG-70H receive FDA 510(k) clearance?

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

Who is the listed applicant for DHX-70H, XTG-70H?

The FDA 510(k) record lists Digimed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Digimed Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220579Hybrid C70K220574HYBRID S70K181891Portable X-ray System (Model: MiniX-V, Mini X-S)

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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