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Fukuda Denshi Model UF-4500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922208

by Fukuda Denshi Usa, Inc.

Identifiers

510(k) Number
K922208 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fukuda Denshi Model UF-4500 is an ultrasound system designed for diagnostic imaging. It is utilized for various clinical applications, including abdominal, small parts, and OB/GYN examinations.

This device has received FDA 510(k) clearance. It is categorized as a class 2 medical device under the product code IYO.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fukuda Denshi Uf-4500 | allmed.wiki, Used Fukuda Denshi UF-4500 Ultrasound - Medverguide, Fukuda Denshi Ultrasound Scanners Models Uf-3500 and Uf-4500 (K981404 ..., Fukuda Denshi Model Uf-4500 - Beudamed, Fukuda UF-4500 Microconvex transducer - eBay

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fukuda Denshi Usa, Inc.

Sources (1)

  • FDA 510(k) K922208 24 fields · synced Sep 21, 2026