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Siemens Gammasonics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
53
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K934766CARBON FIBER PALLETFebruary 18, 1994
K933664POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)December 15, 1993
K933256FAN BEAM COLLIMATOROctober 29, 1993
K920319SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITIOctober 20, 1992
K923582SIENET CAMERA SERVEROctober 14, 1992
K922373MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEMAugust 17, 1992
K922372MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEMAugust 17, 1992
K920310SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVEMarch 30, 1992
K920309SIENET DIAGNOSTIC REPORTING CONSOLEMarch 20, 1992
K914313HICORNovember 27, 1991
K914350ICON COMPUTER SYSTEMNovember 22, 1991
K914179CARDIOFOCAL COLLIMATOROctober 30, 1991
K913630MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEMOctober 23, 1991
K913252LITEBOXAugust 26, 1991
K912481ECT CARBON FIBER PALLET, MODIFICATIONAugust 2, 1991
K912286CARDIAC SPECT PALLETAugust 2, 1991
K905074MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAMJune 21, 1991
K911078MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEMJune 17, 1991
K905199PACSNET RESEARCH TOOLKITJanuary 14, 1991
K903315ICONJanuary 9, 1991