Fukuda Denshi Model UF-850XTD
FDA 510(k) K050363 · Fukuda Denshi USA, Inc.
510(k) numberK050363
Submission
- Device name
- Fukuda Denshi Model UF-850XTD
- Applicant
- Fukuda Denshi USA, Inc.
Redmond, WA, US - Received
- February 14, 2005
- Decision date
- February 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
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Questions and answers
When was Fukuda Denshi Model UF-850XTD cleared by the FDA?
Fukuda Denshi Model UF-850XTD (K050363) received a 510(k) decision of Substantially Equivalent on February 17, 2005, 3 days after the submission was received.
What is the product code of K050363?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.