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FDA 510(k)

PORTABLE X-RAY SYSTEM, MODEL PORT-X II

K-Number: K063121 · 2007-01-11

ApplicantGenoray Co., Ltd.
Decision Date2007-01-11
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTABLE X-RAY SYSTEM, MODEL PORT-X II is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2007-01-11 under 510(k) number K063121. 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 PORT-X II?

PORTABLE X-RAY SYSTEM, MODEL PORT-X II is a medical device that received FDA 510(k) clearance on 2007-01-11. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K063121.

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

PORTABLE X-RAY SYSTEM, MODEL PORT-X II received FDA 510(k) clearance on 2007-01-11, under 510(k) number K063121.

Who is the listed applicant for PORTABLE X-RAY SYSTEM, MODEL PORT-X II?

The FDA 510(k) record lists Genoray 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 PORT-X II?

The FDA product code for PORTABLE X-RAY SYSTEM, MODEL PORT-X II 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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