FDA 510(k)

PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION

K-Number: K083555 · 2008-12-16

Decision Date2008-12-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION is the device name listed in this FDA 510(k) record. The listed applicant is Emsoma Co., Ltd.. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K083555. 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 PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION?

PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Emsoma Co., Ltd.. The 510(k) number is K083555.

When did PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION receive FDA 510(k) clearance?

PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083555.

Who is the listed applicant for PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION?

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

What is the FDA product code for PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION?

The FDA product code for PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION is LLZ.

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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.