EUB-8000
FDA 510(k) K954220 · Hitachi Medical Corp. of America
510(k) numberK954220
Submission
- Device name
- EUB-8000
- Applicant
- Hitachi Medical Corp. of America
Tarrytown, NY, US - Received
- September 11, 1995
- Decision date
- May 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| 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 |
More from Beijing Konted Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K994026 | EUB-6000 Ultrasound Diagnostic ScannerIYN · Traditional | 03/29/2000SE |
| K991535 | Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 07/30/1999SE |
| K991318 | Convergence Nua for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 06/18/1999SE |
| K991129 | Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) CrystalKPS · Traditional | 05/13/1999SE |
| K981434 | EUP-OL334 LaparascopicprobeITX · Traditional | 07/27/1998SE |
| K962308 | EUB-905IYO · Traditional | 07/17/1996SE |
| K954143 | Hitachi Spectradigital Series Gamma Camera SystemsKPS · Traditional | 12/22/1995SE |
| K954129 | Spectradigital Series V250DSPKPS · Traditional | 12/22/1995SE |
| K945400 | Hitachi Dynamic 3D Imaging SYSTEM,SF-VA100IZI · Traditional | 11/20/1995SE |
| K945795 | EUB-555A+IYO · Traditional | 10/27/1995SE |
Questions and answers
When was EUB-8000 cleared by the FDA?
EUB-8000 (K954220) received a 510(k) decision of Substantially Equivalent on May 7, 1997, 604 days after the submission was received.
What is the product code of K954220?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.