EUP-V12 5.0 MHZ Convex Array Transvaginal Probe
FDA 510(k) K900966 · Hitachi Medical Corp. of America
510(k) numberK900966
Submission
- Device name
- EUP-V12 5.0 MHZ Convex Array Transvaginal Probe
- Applicant
- Hitachi Medical Corp. of America
Tarrytown, NY, US - Received
- March 1, 1990
- Decision date
- September 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGL – Transducer, Ultrasonic, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2960
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | Advanced Medical Systems, Inc. | 07/18/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | Advanced Medical Systems, Inc. | 07/22/1994SE |
| K924516 | OP3/VP4HGL · Traditional | Huntleigh Technology, Inc. | 06/28/1993SE |
| K903348 | Ultrasonic Pulsed Doppler Imaging SystemHGL · Traditional | Advanced Technology Laboratories, Inc. | 10/22/1990SE |
| K903316 | Aloka UST-964P-5 Endovaginal TransducerHGL · Traditional | Ge Medical Systems Information Technologies | 08/22/1990SE |
| K901142 | Mer Multiplane Vaginal Probe (MVP)HGL · Traditional | Medical Equipment Resources | 08/22/1990SE |
| K900838 | Transvaginal Transducer AssemblyHGL · Traditional | Pie Medical Equipment B.V. | 05/23/1990SE |
| K895449 | Aloka Model SSD-650 Ultrasound Imaging SystemHGL · Traditional | Ge Medical Systems Information Technologies | 03/05/1990SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | Multigon Industries, Inc. | 01/05/1990SE |
| K895647 | 5.0 MHZ Convex Array Intravaginal TransducerHGL · Traditional | Advanced Technology Laboratories, Inc. | 12/18/1989SE |
More from Advanced Technology Laboratories, Inc.
| 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 |
| K954220 | EUB-8000IYN · Traditional | 05/07/1997SE |
| 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 |
Questions and answers
When was EUP-V12 5.0 MHZ Convex Array Transvaginal Probe cleared by the FDA?
EUP-V12 5.0 MHZ Convex Array Transvaginal Probe (K900966) received a 510(k) decision of Substantially Equivalent on September 12, 1990, 195 days after the submission was received.
What is the product code of K900966?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.