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 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
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 28d
Cleared Mar 05, 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 194d
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 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 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
ACUSON TV519 TRANSDUCER
K864578
Acuson Computed Sonography
Obstetrics & Gynecology · 127d
Cleared Mar 27, 1987
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K864908
Diasonics, Inc.
Obstetrics & Gynecology · 102d
Cleared Mar 27, 1987
7.5 MHZ ENDOVAGINAL PROBE
K870709
Philips Ultrasound, Inc.
Obstetrics & Gynecology · 35d
Cleared Jul 14, 1986
TRANSVAGINAL PROBE, MODEL ED65M-TV
K861371
Elscint, Inc.
Obstetrics & Gynecology · 94d
Cleared Jun 19, 1986
ACUSON S228, S519 & L558 TRANSDUCERS
K861577
Acuson Computed Sonography
Obstetrics & Gynecology · 52d
Cleared Jun 17, 1986
ACUSON S328, L382, L538 & L312 TRANSDUCERS
K861578
Acuson Computed Sonography
Obstetrics & Gynecology · 50d
Cleared May 23, 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234
Philips Medical Systems, Inc.
Obstetrics & Gynecology · 121d
Cleared Mar 17, 1986
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 48d
Cleared Aug 04, 1977
ARTIUS SYSTEM
K771151
General Electric Co.
Obstetrics & Gynecology · 41d

About Product Code HGL - Regulatory Context