HEM — Imager, Ultrasonic Obstetric-Gynecologic Class II

FDA Device Classification

Classification Details

Product Code
HEM
Device Class
Class II
Regulation Number
884.2225
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951393solomon technology labsABACUS OB ULTRASOUNG COMPUTER SOFTWAREMay 1, 1995
K942490medical softBABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDFebruary 15, 1995
K910426shimadzu medical systemsSDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTJune 6, 1991
K905000corometrics medical systemsALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERJanuary 31, 1991
K900505medison coSONOACE 88 PORTABLE ULTRASOUND SCANNERAugust 10, 1990
K900271digisonicsMODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKApril 19, 1990
K890637elscintEXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEJune 12, 1989
K881329advanced technology laboratoriesFETAL DOPPLER FOR ULTRAMARK 4 AND 8April 14, 1989
K885061siemens medical solutions usaSIEMENS INTRAVAGINAL TRANSDUCERFebruary 23, 1989
K881185philips medical systems (cleveland)ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.June 1, 1988
K880900corometrics medical systemsSSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNERJune 1, 1988
K862364swemed laboratoriesNEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)August 19, 1986
K862627ausonics ptySONORANGER TRANSVAGINAL PROBEAugust 1, 1986
K861931ge medical systems information technologies645OB SECTOR/LINEAR ULTRASOUND SCANNERJuly 31, 1986
K860233general electric5 MHZ INTRACAVITARY PROBE, MODEL H4222VJune 2, 1986
K853711general electric5.0 MHZ INTRACAVITARY SECTOR PROBEDecember 18, 1985
K851902fukuda denshi usaMODEL U-1000 ULTRASONIC SCANNERSeptember 27, 1985
K853407advanced technology laboratoriesINTRA VAGINAL TRANSDUCERSeptember 27, 1985
K852439international biomedicsFETA SCAN 1000 OBSTETRICAL IMAGERAugust 30, 1985
K842261ge medical systems information technologiesOB ULTRASOUND LINEAR SCANNER 630September 19, 1984