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FDA 510(k)

Exam Vue PACS

K-Number: K162868 · 2017-03-17

ApplicantJpi Healthcare Solutions, Inc.
Decision Date2017-03-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Exam Vue PACS is a medical device manufactured by Jpi Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2017-03-17 under approval number K162868. 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 Exam Vue PACS?

Exam Vue PACS is a medical device that received FDA 510(k) clearance on 2017-03-17. It is manufactured by Jpi Healthcare Solutions, Inc.. The 510(k) number is K162868.

When was Exam Vue PACS approved by the FDA?

Exam Vue PACS received FDA 510(k) clearance on 2017-03-17, under approval number K162868.

What company makes Exam Vue PACS?

Exam Vue PACS is manufactured by Jpi Healthcare Solutions, Inc..

What is the FDA product code for Exam Vue PACS?

The FDA product code for Exam Vue PACS 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.

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