FDA 510(k)

Restore PACS

K-Number: K162141 · 2016-09-02

ApplicantXian Wingspan Electronic Technology Co., Ltd.

Decision Date2016-09-02

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Restore PACS is the device name listed in this FDA 510(k) record. The listed applicant is Xian Wingspan Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K162141. 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 Restore PACS?

Restore PACS is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Xian Wingspan Electronic Technology Co., Ltd.. The 510(k) number is K162141.

When did Restore PACS receive FDA 510(k) clearance?

Restore PACS received FDA 510(k) clearance on 2016-09-02, under 510(k) number K162141.

Who is the listed applicant for Restore PACS?

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

What is the FDA product code for Restore PACS?

The FDA product code for Restore PACS is LLZ.

Related Devices (Code: LLZ)

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.