FDA Product Code HEM: Imager, Ultrasonic Obstetric-gynecologic
Leading manufacturers include General Electric Co., Ge Medical Systems Information Technologies and Advanced Technology Laboratories, Inc..
30
Total
30
Cleared
92d
Avg days
1976
Since
FDA 510(k) Cleared Imager, Ultrasonic Obstetric-gynecologic Devices (Product Code HEM)
30 devices
Cleared
Jun 06, 1991
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
Shimadzu Medical Systems
Obstetrics & Gynecology
127d
Cleared
Jun 12, 1989
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
Elscint, Inc.
Obstetrics & Gynecology
124d
Cleared
Apr 14, 1989
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology
380d
Cleared
Feb 23, 1989
SIEMENS INTRAVAGINAL TRANSDUCER
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology
79d
Cleared
Jun 01, 1988
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
Philips Medical Systems (Cleveland), Inc.
Obstetrics & Gynecology
72d
Cleared
Jul 31, 1986
645OB SECTOR/LINEAR ULTRASOUND SCANNER
Ge Medical Systems Information Technologies
Obstetrics & Gynecology
72d
Cleared
Jun 02, 1986
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
General Electric Co.
Obstetrics & Gynecology
131d
Cleared
Dec 18, 1985
5.0 MHZ INTRACAVITARY SECTOR PROBE
General Electric Co.
Obstetrics & Gynecology
104d
Cleared
Sep 27, 1985
MODEL U-1000 ULTRASONIC SCANNER
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology
150d
Cleared
Sep 27, 1985
INTRA VAGINAL TRANSDUCER
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology
46d
Cleared
Sep 19, 1984
OB ULTRASOUND LINEAR SCANNER 630
Ge Medical Systems Information Technologies
Obstetrics & Gynecology
104d
Cleared
Mar 13, 1981
DATASON DB ULTRASOUND IMAGING SYSTEM
General Electric Co.
Obstetrics & Gynecology
36d
Cleared
Dec 16, 1976
V.I. OCTOSON ULTRASONIC SYSTEM
General Electric Co.
Obstetrics & Gynecology
59d
Cleared
Dec 16, 1976
REAL TIME OBSTETRICAL ULTRASONIC SCANNER
Smithkline Diagnostics, Inc.
Obstetrics & Gynecology
31d