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FDA 510(k)

Portable X-ray System (Model: MiniX-V, Mini X-S)

K-Number: K181891 · 2018-08-10

ApplicantDigimed Co., Ltd.
Decision Date2018-08-10
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable X-ray System (Model: MiniX-V, Mini X-S) is a medical device manufactured by Digimed Co., Ltd.. It received FDA 510(k) clearance on 2018-08-10 under approval number K181891. 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 (Model: MiniX-V, Mini X-S)?

Portable X-ray System (Model: MiniX-V, Mini X-S) is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by Digimed Co., Ltd.. The 510(k) number is K181891.

When was Portable X-ray System (Model: MiniX-V, Mini X-S) approved by the FDA?

Portable X-ray System (Model: MiniX-V, Mini X-S) received FDA 510(k) clearance on 2018-08-10, under approval number K181891.

What company makes Portable X-ray System (Model: MiniX-V, Mini X-S)?

Portable X-ray System (Model: MiniX-V, Mini X-S) is manufactured by Digimed Co., Ltd..

What is the FDA product code for Portable X-ray System (Model: MiniX-V, Mini X-S)?

The FDA product code for Portable X-ray System (Model: MiniX-V, Mini X-S) is EHD.

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Other Devices by Digimed Co., Ltd.

K220579Hybrid C70 K220574HYBRID S70 K221587DHX-70H, XTG-70H

Related Devices (Code: EHD)

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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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