FDA 510(k) Applications Submitted by STEVEN KAY
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K974344 |
11/19/1997 |
CT SCOPE |
ELSCINT, INC. |
K121578 |
05/30/2012 |
ATOM 1 (MODEL: BRC 2200) |
BIOELECTRIC RESEARCH CORPORATION |
K970047 |
01/06/1997 |
PHASED ARRAY TRANSDUCER - - PSK-20CT |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K960602 |
01/16/1996 |
SSA-340A (MODIFICATION) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K980306 |
01/27/1998 |
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP |
ELSCINT, INC. |
K961842 |
05/13/1996 |
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM |
TOSHIBA AMERICA MRI, INC. |
K982060 |
06/11/1998 |
VOLUMAX CT IMAGING SYSTEM |
ELSCINT, INC. |
K972771 |
07/24/1997 |
PHASED ARRAY TRANSDUCER - - PVF -375DT |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K962933 |
07/29/1996 |
OPART MRT-600 |
TOSHIBA AMERICA MRI, INC. |
K963705 |
09/16/1996 |
COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K983313 |
09/21/1998 |
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY |
ELSCINT, INC. |
K964608 |
11/18/1996 |
MRT-35A V9.0 |
TOSHIBA AMERICA MRI, INC. |
K964865 |
12/04/1996 |
PVK-720ST ENDOCAVITARY TRANSDUCER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K974614 |
12/11/1997 |
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 |
ELSCINT, INC. |
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