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FDA 510(k)

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System

K-Number: K200022 · 2020-04-03

ApplicantLivermoretech, Inc.
Decision Date2020-04-03
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is a medical device manufactured by Livermoretech, Inc.. It received FDA 510(k) clearance on 2020-04-03 under approval number K200022. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2020-04-03. It is manufactured by Livermoretech, Inc.. The 510(k) number is K200022.

When was FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System approved by the FDA?

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System received FDA 510(k) clearance on 2020-04-03, under approval number K200022.

What company makes FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is manufactured by Livermoretech, Inc..

What is the FDA product code for FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

The FDA product code for FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is OWB.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Livermoretech, Inc.

K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEM K190935EZER, Portable X-ray System K193535EZER, Portable X-ray System K193644E-COM DR-2000 DR K244049Europa (Alternative: AiRTouch) portable X-ray system

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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.

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