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)

FS-PACS

K-Number: K152034 · 2016-02-23

ApplicantEc-Web Co., Ltd.
Decision Date2016-02-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FS-PACS is a medical device manufactured by Ec-Web Co., Ltd.. It received FDA 510(k) clearance on 2016-02-23 under approval number K152034. 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 FS-PACS?

FS-PACS is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Ec-Web Co., Ltd.. The 510(k) number is K152034.

When was FS-PACS approved by the FDA?

FS-PACS received FDA 510(k) clearance on 2016-02-23, under approval number K152034.

What company makes FS-PACS?

FS-PACS is manufactured by Ec-Web Co., Ltd..

What is the FDA product code for FS-PACS?

The FDA product code for FS-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.

↑