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Elscint, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
94
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYDecember 11, 1998
K982060VOLUMAX CT IMAGING SYSTEMSeptember 2, 1998
K974344CT SCOPEJune 3, 1998
K980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPApril 2, 1998
K974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102March 4, 1998
K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)September 15, 1997
K970680GLORYJune 20, 1997
K965044GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102June 16, 1997
K970980CARDIAC SCORING FOR CT SCANNERSMay 29, 1997
K970005GYREX 2T-PRESTIGEMarch 28, 1997
K964583XRT-7.0January 17, 1997
K962100VOLMETRIC COINCIDENCE DETECTION SYSTEMJanuary 10, 1997
K963162QUANTEMNovember 12, 1996
K962618GYREX V-EPSeptember 4, 1996
K961464SELECT/SPJuly 3, 1996
K935024ESI-5000June 12, 1996
K960381MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTIONApril 29, 1996
K954039GYREX PRIVILEGENovember 24, 1995
K953801VARICAMNovember 22, 1995
K952674TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERASeptember 26, 1995