Elscint, Inc. - FDA 510(k) Cleared Devices
94
Total
94
Cleared
0
Denied
87 devices
Cleared
Aug 24, 1994
GYREX 2T-SGR
Radiology
280d
Cleared
Aug 23, 1994
ADVANCED AUTOMATIC KV
Radiology
319d
Cleared
Jul 29, 1994
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
Radiology
430d
Cleared
Jun 27, 1994
VOLUME NECK COIL FOR THE GYREX V-DIX
Radiology
238d
Cleared
Feb 18, 1994
APEX SPX CARDIAL
Radiology
261d
Cleared
Oct 08, 1993
ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT
Radiology
336d
Cleared
Oct 07, 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
Radiology
316d
Cleared
Aug 23, 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
Radiology
214d
Cleared
Mar 19, 1993
HELICAT
Radiology
70d
Cleared
Oct 21, 1992
A BREAST COIL FOR THE GYREX 2T-DIX
Radiology
78d
Cleared
Jul 21, 1992
EXCEL CT TWIN
Radiology
214d
Cleared
Feb 27, 1992
APEX HELIX - A
Radiology
125d
Cleared
Feb 18, 1992
3D PROCESSING OPTIONS FOR GYREX
Radiology
67d
Cleared
Feb 14, 1992
GYREX 2T-DLX
Radiology
63d
Cleared
Feb 04, 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
Radiology
43d
Cleared
Jan 31, 1992
SPECIAL PURPOSE COILS FOR GYREX V
Radiology
49d
Cleared
Sep 19, 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
Radiology
73d
Cleared
Mar 05, 1991
ESI-3000 ULTRASOUND SYSTEM
Radiology
162d
Cleared
Sep 10, 1990
GYREX 2T VERSION 2.1U.
Radiology
61d
Cleared
Jul 25, 1990
MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
Radiology
194d
Cleared
Feb 02, 1990
MODEL: GYREX VERSION V
Radiology
86d
Cleared
Sep 07, 1989
ELSCINT'S EXEL 2400E CT SCANNER
Radiology
49d
Cleared
Apr 17, 1989
APEX 115 NUCLEAR MEDICINE PROCESSOR
Radiology
160d
Cleared
Apr 17, 1989
APEX 415 ANGER CAMERA
Radiology
160d
Cleared
Apr 17, 1989
APEX 609R ANGER CAMERA
Radiology
160d
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