Ultrasound Transducer, Model US917
FDA 510(k) K952031 · Advanced Medical Systems, Inc.
510(k) numberK952031
Submission
- Device name
- Ultrasound Transducer, Model US917
- Applicant
- Advanced Medical Systems, Inc.
Hamden, CT, US - Received
- May 1, 1995
- Decision date
- July 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K955931 | Model IM77 Intrapartum Fetal Monitor (Modification)HGM · Traditional | 08/14/1996SE |
| K940898 | Model IM77 Intrapartum Fetal MonitorHGM · Traditional | 03/01/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | 07/22/1994SE |
| K932278 | PFM Professional 7000 SpirometerBTY · Traditional | 12/17/1993SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | 07/11/1991SE |
| K902190 | Fetal Pulse Detector Model DOP-1HEK · Traditional | 10/22/1990SE |
| K894568 | New RAD-8 Treatment Planning Computer SystemKPQ · Traditional | 01/09/1990SE |
| K891672 | Pul-Tron 100K Professional SpirometerBZG · Traditional | 06/16/1989SE |
| K880756 | Model PM-20A Physiological MonitorDQA · Traditional | 09/27/1988SE |
Questions and answers
When was Ultrasound Transducer, Model US917 cleared by the FDA?
Ultrasound Transducer, Model US917 (K952031) received a 510(k) decision of Substantially Equivalent on July 18, 1995, 78 days after the submission was received.
What is the product code of K952031?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.