EUB-905
FDA 510(k) K962308 · Hitachi Medical Corp. of America
510(k) numberK962308
Submission
- Device name
- EUB-905
- Applicant
- Hitachi Medical Corp. of America
Tarrytown, NY, US - Received
- June 17, 1996
- Decision date
- July 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
| K994026 | EUB-6000 Ultrasound Diagnostic ScannerIYN · Traditional | 03/29/2000SE |
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| 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 |
| K954220 | EUB-8000IYN · Traditional | 05/07/1997SE |
| 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-905 cleared by the FDA?
EUB-905 (K962308) received a 510(k) decision of Substantially Equivalent on July 17, 1996, 30 days after the submission was received.
What is the product code of K962308?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.