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)

IGTFusion

K-Number: K180522 · 2018-08-16

ApplicantIgi Technologies
Decision Date2018-08-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IGTFusion is a medical device manufactured by Igi Technologies. It received FDA 510(k) clearance on 2018-08-16 under approval number K180522. 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 IGTFusion?

IGTFusion is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Igi Technologies. The 510(k) number is K180522.

When was IGTFusion approved by the FDA?

IGTFusion received FDA 510(k) clearance on 2018-08-16, under approval number K180522.

What company makes IGTFusion?

IGTFusion is manufactured by Igi Technologies.

What is the FDA product code for IGTFusion?

The FDA product code for IGTFusion 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.

↑