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FDA 510(k)

ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM

K-Number: K103425 · 2011-03-29

ApplicantGenoray America, Inc.
Decision Date2011-03-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genoray America, Inc.. It received FDA 510(k) clearance on 2011-03-29 under 510(k) number K103425. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM?

ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-29. The listed applicant is Genoray America, Inc.. The 510(k) number is K103425.

When did ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM receive FDA 510(k) clearance?

ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM received FDA 510(k) clearance on 2011-03-29, under 510(k) number K103425.

Who is the listed applicant for ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM?

The FDA 510(k) record lists Genoray America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM?

The FDA product code for ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM is OWB.

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Related Devices (Code: OWB)

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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