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)

FX SPS

K-Number: K213922 · 2022-07-22

ApplicantPixee Medical
Decision Date2022-07-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FX SPS is a medical device manufactured by Pixee Medical. It received FDA 510(k) clearance on 2022-07-22 under approval number K213922. 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 FX SPS?

FX SPS is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Pixee Medical. The 510(k) number is K213922.

When was FX SPS approved by the FDA?

FX SPS received FDA 510(k) clearance on 2022-07-22, under approval number K213922.

What company makes FX SPS?

FX SPS is manufactured by Pixee Medical.

What is the FDA product code for FX SPS?

The FDA product code for FX SPS is LLZ.

Other Devices by Pixee Medical

K202750Knee+ K220104Knee+ K230789Knee+ K233899Knee+ K243975Knee+

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.

↑