Aloka UST-964P-5 Endovaginal Transducer
FDA 510(k) K903316 · Ge Medical Systems Information Technologies
510(k) numberK903316
Submission
- Device name
- Aloka UST-964P-5 Endovaginal Transducer
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- July 25, 1990
- Decision date
- August 22, 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 |
| K900966 | EUP-V12 5.0 MHZ Convex Array Transvaginal ProbeHGL · Traditional | Hitachi Medical Corp. of America | 09/12/1990SE |
| 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 |
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Questions and answers
When was Aloka UST-964P-5 Endovaginal Transducer cleared by the FDA?
Aloka UST-964P-5 Endovaginal Transducer (K903316) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 28 days after the submission was received.
What is the product code of K903316?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.