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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 the device name listed in this FDA 510(k) record. The listed applicant is Livermoretech, Inc.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) 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. The listed applicant is Livermoretech, Inc.. The 510(k) number is K200022.

When did FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System receive FDA 510(k) clearance?

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

Who is the listed applicant for FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

The FDA 510(k) record lists Livermoretech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Livermoretech, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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