Advanced Technology Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
61
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021966Q LAB SOFTWAREJuly 2, 2002
K011224HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMay 4, 2001
K002144MEDLINK DIAGNOSTIC OFFLINE WORKSTATIONSeptember 28, 2000
K992470ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEMAugust 23, 1999
K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMJune 18, 1999
K961459LEVEL 10 HDIMarch 26, 1997
K935009PEGASUSOctober 11, 1994
K940423NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULEJuly 29, 1994
K905248NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMSFebruary 28, 1991
K903603ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)February 26, 1991
K901329CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEMNovember 23, 1990
K902214BIOPSY NEEDLE TRANSPONDER SYSTEMNovember 8, 1990
K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMOctober 22, 1990
K897004NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEMMarch 13, 1990
K896543ULTRAMARK 7 ULTRASOUND SYSTEMFebruary 15, 1990
K8956475.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERDecember 18, 1989
K8951235.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERNovember 13, 1989
K8940545.0 MHZ ARRAY INTRAVAGINAL TRANSDUCERSeptember 12, 1989
K8913095.0 MHZ ARRAY INTRAVAGINAL TRANSDUCERMay 16, 1989
K881329FETAL DOPPLER FOR ULTRAMARK 4 AND 8April 14, 1989