HEM · Class II · 21 CFR 884.2225

FDA Product Code HEM: Imager, Ultrasonic Obstetric-gynecologic

Leading manufacturers include General Electric Co., Advanced Technology Laboratories, Inc. and Corometrics Medical Systems, Inc..

30
Total
30
Cleared
92d
Avg days
1976
Since
30 devices
25–30 of 30
Cleared Mar 13, 1981
DATASON DB ULTRASOUND IMAGING SYSTEM
K810305
General Electric Co.
Obstetrics & Gynecology · 36d
Cleared Jun 27, 1978
ULTRASONIC IMAGER
K780876
Air-Shields, Inc.
Radiology · 28d
Cleared Oct 19, 1977
ROCHE AXISCAN 5
K771816
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 22d
Cleared Apr 14, 1977
ULTRASOUND B-SCANNING SYSTEM
K770644
Unirad Corp.
Obstetrics & Gynecology · 10d
Cleared Dec 16, 1976
V.I. OCTOSON ULTRASONIC SYSTEM
K760874
General Electric Co.
Obstetrics & Gynecology · 59d
Cleared Dec 16, 1976
REAL TIME OBSTETRICAL ULTRASONIC SCANNER
K761052
Smithkline Diagnostics, Inc.
Obstetrics & Gynecology · 31d