Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with Doppler
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990401 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 FF Sonic UF-5800 is a general purpose ultrasound scanning system with Doppler capability. It projects ultrasound waves into body tissue and processes returned echoes to generate 16-level grayscale or black-and-white images.
This Class II ultrasound system is manufactured by Fukuda Denshi USA, Inc. and was cleared under FDA 510(k) K990401 on October 15, 1999. It is used in radiology settings and is supplied as a non-sterile, reusable device. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.
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 Ff Sonic Uf-5800 General Purpose Ultrasound Scanning ..., Fukuda Denshi FF Sonic Uf-5800 Ultrasound Scanning With…, fda.innolitics.com, Fukuda-Denshi-Usa FDA Filings - FDA.report, Customer and Technical Support | Fukuda Denshi
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990401 | Class II | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Usa, Inc.
Sources (1)
- FDA 510(k) K990401 24 fields · synced Sep 26, 2026