HGL · Class II · 21 CFR 884.2960

FDA Product Code HGL: Transducer, Ultrasonic, Obstetric

Leading manufacturers include Advanced Technology Laboratories, Inc., Acuson Computed Sonography and Ge Medical Systems Information Technologies.

36
Total
36
Cleared
140d
Avg days
1977
Since

FDA 510(k) Cleared Transducer, Ultrasonic, Obstetric Devices (Product Code HGL)

36 devices
1–24 of 36
Cleared Jul 18, 1995
ULTRASOUND TRANSDUCER, MODEL US917
K952031
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 78d
Cleared Jul 22, 1994
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
K923335
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 774d
Cleared Jun 28, 1993
OP3/VP4
K924516
Huntleigh Technology, Inc.
Radiology · 297d
Cleared Oct 22, 1990
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 88d
Cleared Sep 12, 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966
Hitachi Medical Corp. of America
Obstetrics & Gynecology · 195d
Cleared Aug 22, 1990
MER MULTIPLANE VAGINAL PROBE (MVP)
K901142
Medical Equipment Resources
Obstetrics & Gynecology · 163d
Cleared Aug 22, 1990
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 28d
Cleared May 23, 1990
TRANSVAGINAL TRANSDUCER ASSEMBLY
K900838
Pie Medical Equipment B.V.
Obstetrics & Gynecology · 90d
Cleared Mar 05, 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 194d
Cleared Jan 05, 1990
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
K881263
Multigon Industries, Inc.
Obstetrics & Gynecology · 652d
Cleared Dec 18, 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895647
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 89d
Cleared Nov 13, 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895123
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 06, 1989
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026
Hewlett-Packard Co.
Obstetrics & Gynecology · 90d
Cleared Oct 25, 1989
DYMAX ENDOVAGINAL BIOPSY GUIDE
K894415
Dymax Corp
Obstetrics & Gynecology · 100d
Cleared Sep 05, 1989
GENERAL IVT NEEDLE GUIDE KIT, STERILE
K892070
Amedic USA
Obstetrics & Gynecology · 158d
Cleared Aug 02, 1988
SIEMENS INTRAVAGINAL TRANSDUCER
K881405
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology · 120d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875334
Kontron Instruments, Inc.
Obstetrics & Gynecology · 85d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875371
Kontron Instruments, Inc.
Obstetrics & Gynecology · 84d
Cleared Jan 04, 1988
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
K872265
Labsonics, Inc.
Obstetrics & Gynecology · 207d
Cleared Aug 28, 1987
ANNULAR ARRAY SCANHEAD
K871856
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 108d
Cleared Mar 27, 1987
BIOPSY NEEDLE GUIDE ATTACHMENT
K863797
Elscint, Inc.
Obstetrics & Gynecology · 179d
Cleared Mar 27, 1987
280SL IMAGING SYSTEM TRANVAGINAL PROBES
K864151
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 155d
Cleared Mar 27, 1987
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
K864219
Amedic USA
Obstetrics & Gynecology · 150d
Cleared Mar 27, 1987
ACUSON TV519 TRANSDUCER
K864578
Acuson Computed Sonography
Obstetrics & Gynecology · 127d

About Product Code HGL - Regulatory Context