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FDA 510(k) Applications Submitted by THOMAS J SPACKMAN, M.D.,F.A.C.R.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K970005
01/02/1997
GYREX 2T-PRESTIGE
ELSCINT, INC.
K970980
03/18/1997
CARDIAC SCORING FOR CT SCANNERS
ELSCINT, INC.
K962100
05/30/1996
VOLMETRIC COINCIDENCE DETECTION SYSTEM
ELSCINT, INC.
K962618
07/03/1996
GYREX V-EP
ELSCINT, INC.
K965044
12/13/1996
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
ELSCINT, INC.
K964583
11/15/1996
XRT-7.0
ELSCINT, INC.
K960381
01/26/1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
ELSCINT, INC.
K961464
04/17/1996
SELECT/SP
ELSCINT, INC.
K963162
08/14/1996
QUANTEM
ELSCINT, INC.
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