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FDA 510(k)

PORTABLE X-RAY SYSTEM, MODEL DXR -1

K-Number: K082875 · 2009-02-05

ApplicantExaro Co., Ltd.
Decision Date2009-02-05
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTABLE X-RAY SYSTEM, MODEL DXR -1 is the device name listed in this FDA 510(k) record. The listed applicant is Exaro Co., Ltd.. It received FDA 510(k) clearance on 2009-02-05 under 510(k) number K082875. 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 DXR -1?

PORTABLE X-RAY SYSTEM, MODEL DXR -1 is a medical device that received FDA 510(k) clearance on 2009-02-05. The listed applicant is Exaro Co., Ltd.. The 510(k) number is K082875.

When did PORTABLE X-RAY SYSTEM, MODEL DXR -1 receive FDA 510(k) clearance?

PORTABLE X-RAY SYSTEM, MODEL DXR -1 received FDA 510(k) clearance on 2009-02-05, under 510(k) number K082875.

Who is the listed applicant for PORTABLE X-RAY SYSTEM, MODEL DXR -1?

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

What is the FDA product code for PORTABLE X-RAY SYSTEM, MODEL DXR -1?

The FDA product code for PORTABLE X-RAY SYSTEM, MODEL DXR -1 is EHD.

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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

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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