Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Xian Wingspan Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-09-02 under approval 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. It is manufactured by Xian Wingspan Electronic Technology Co., Ltd.. The 510(k) number is K162141.

When was Restore PACS approved by the FDA?

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

What company makes Restore PACS?

Restore PACS is manufactured by Xian Wingspan Electronic Technology Co., Ltd..

What is the FDA product code for Restore PACS?

The FDA product code for Restore PACS is LLZ.

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑