Diasonics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K962662VINGMED SOUND COLOR FLOW MAPPING SYSTEMJanuary 2, 1997
K924079CFM-800 COLOR FLOW MAPPING SYSTEMSeptember 28, 1993
K911435CPA/3.5 MHZ PROBESeptember 11, 1992
K905200SACA, 3.5 MHZ PROBEApril 2, 1992
K903562CW DOPPLER 2.25 MHZ PROBEMarch 2, 1992
K903984CW DOPPLER/4.5 MHZJune 14, 1991
K896637ACCESS(TM), SOFTWARE RELEASE 4.11PJanuary 22, 1990
K893518MT/S SOFTWARE RELEASE 5.0.October 27, 1989
K894290ACCESS TMSeptember 7, 1989
K893881ACCESS TMJune 23, 1989
K891452SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULEJune 7, 1989
K891541MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.May 11, 1989
K884816ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORYFebruary 2, 1989
K884607MT/S (SOFTWARE RELEASE 3.1)December 21, 1988
K884606MT/S (SPINE TRANSMIT COIL)December 5, 1988
K884743TEMPOROMANDIBULAR JOINT COIL (TMJ)December 5, 1988
K884603SHOULDER TRANSMIT AND RECEIVE COILSNovember 30, 1988
K884604MT/S CARLSON SPINE COIL, PART # 100-50082500-01November 30, 1988
K882478100-01778-52 ULTRASOUND SYSTEMOctober 12, 1988
K883516DIASONICS MT/P IMAGING SYSTEMOctober 7, 1988