HEM · Class II · 21 CFR 884.2225

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
1–24 of 30
Cleared May 01, 1995
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
K951393
Solomon Technology Labs
Obstetrics & Gynecology · 35d
Cleared Feb 15, 1995
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND
K942490
Medical Soft, Inc.
Obstetrics & Gynecology · 266d
Cleared Jun 06, 1991
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K910426
Shimadzu Medical Systems
Obstetrics & Gynecology · 127d
Cleared Jan 31, 1991
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K905000
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 85d
Cleared Aug 10, 1990
SONOACE 88 PORTABLE ULTRASOUND SCANNER
K900505
Medison Co., Ltd.
Obstetrics & Gynecology · 189d
Cleared Apr 19, 1990
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK
K900271
Digisonics, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 12, 1989
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
K890637
Elscint, Inc.
Obstetrics & Gynecology · 124d
Cleared Apr 14, 1989
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
K881329
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 380d
Cleared Feb 23, 1989
SIEMENS INTRAVAGINAL TRANSDUCER
K885061
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology · 79d
Cleared Jun 01, 1988
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
K880900
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 01, 1988
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
K881185
Philips Medical Systems (Cleveland), Inc.
Obstetrics & Gynecology · 72d
Cleared Aug 19, 1986
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
K862364
Swemed Laboratories, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 01, 1986
SONORANGER TRANSVAGINAL PROBE
K862627
Ausonics Pty , Ltd.
Obstetrics & Gynecology · 22d
Cleared Jul 31, 1986
645OB SECTOR/LINEAR ULTRASOUND SCANNER
K861931
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 72d
Cleared Jun 02, 1986
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K860233
General Electric Co.
Obstetrics & Gynecology · 131d
Cleared Dec 18, 1985
5.0 MHZ INTRACAVITARY SECTOR PROBE
K853711
General Electric Co.
Obstetrics & Gynecology · 104d
Cleared Sep 27, 1985
MODEL U-1000 ULTRASONIC SCANNER
K851902
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology · 150d
Cleared Sep 27, 1985
INTRA VAGINAL TRANSDUCER
K853407
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 46d
Cleared Aug 30, 1985
FETA SCAN 1000 OBSTETRICAL IMAGER
K852439
International Biomedics, Inc.
Obstetrics & Gynecology · 81d
Cleared Sep 19, 1984
OB ULTRASOUND LINEAR SCANNER 630
K842261
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 104d
Cleared May 11, 1984
OBSTETRICAL ULTRASOUND COMPUTER
K840623
R & S Systems
Obstetrics & Gynecology · 87d
Cleared Dec 15, 1983
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
K834088
Whs Products, Inc.
Obstetrics & Gynecology · 92d
Cleared Nov 28, 1983
SONICOMP
K833488
Sonicaid, Inc.
Obstetrics & Gynecology · 52d
Cleared Jul 02, 1981
GRAYLINE IMAGING SYSTEM
K811520
Sonics Research Corp.
Radiology · 34d

About Product Code HEM - Regulatory Context