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FDA 510(k)

ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

K-Number: K103181 · 2011-08-26

ApplicantGenoray Co., Ltd.
Decision Date2011-08-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM 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 2011-08-26 under 510(k) number K103181. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM?

ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-26. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K103181.

When did ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM receive FDA 510(k) clearance?

ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM received FDA 510(k) clearance on 2011-08-26, under 510(k) number K103181.

Who is the listed applicant for ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM?

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 ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM?

The FDA product code for ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM is LLZ.

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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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