HGL · Transducer, Ultrasonic, Obstetric
Obstetrics/Gynecology · 21 CFR 884.2960 · Class 2
Overview
| Product Code | HGL |
|---|---|
| Device Name | Transducer, Ultrasonic, Obstetric |
| Regulation | 21 CFR 884.2960 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | Advanced Medical Systems, Inc. | Jul 18, 1995 | SESE |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | Advanced Medical Systems, Inc. | Jul 22, 1994 | SESE |
| K924516 | OP3/VP4 | Huntleigh Technology, Inc. | Jun 28, 1993 | SESE |
| K903348 | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | Advanced Technology Laboratories, Inc. | Oct 22, 1990 | SESE |
| K900966 | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE | Hitachi Medical Corp. of America | Sep 12, 1990 | SESE |
| K903316 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Ge Medical Systems Information Technologies | Aug 22, 1990 | SESE |
| K901142 | MER MULTIPLANE VAGINAL PROBE (MVP) | Medical Equipment Resources | Aug 22, 1990 | SESE |
| K900838 | TRANSVAGINAL TRANSDUCER ASSEMBLY | Pie Medical Equipment B.V. | May 23, 1990 | SESE |
| K895449 | ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM | Ge Medical Systems Information Technologies | Mar 5, 1990 | SESE |
| K881263 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER | Multigon Industries, Inc. | Jan 5, 1990 | SESE |
| K895647 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | Dec 18, 1989 | SESE |
| K895123 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | Nov 13, 1989 | SESE |
| K895026 | HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER | Hewlett-Packard Co. | Nov 6, 1989 | SESE |
| K894415 | DYMAX ENDOVAGINAL BIOPSY GUIDE | Dymax Corp | Oct 25, 1989 | SESE |
| K892070 | GENERAL IVT NEEDLE GUIDE KIT, STERILE | Amedic USA | Sep 5, 1989 | SESE |
| K881405 | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | Aug 2, 1988 | SESE |
| K875371 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | Mar 24, 1988 | SESE |
| K875334 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | Mar 24, 1988 | SESE |
| K872265 | ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. | Labsonics, Inc. | Jan 4, 1988 | SESE |
| K871856 | ANNULAR ARRAY SCANHEAD | Advanced Technology Laboratories, Inc. | Aug 28, 1987 | SN |
Top Applicants
- Advanced Technology Laboratories, Inc. — 4 clearances
- Acuson Computed Sonography — 3 clearances
- Ge Medical Systems Information Technologies — 3 clearances
- Advanced Medical Systems, Inc. — 2 clearances
- Amedic USA — 2 clearances
