FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

94 results for "Elscint, Inc."
1–24 of 94
Search insights Median review: 83d Cleared: 100% Top manufacturer: Elscint, Inc. Lead specialty: Radiology
Cleared Dec 11, 1998
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313 · IZH
Elscint, Inc.
Radiology · 81d
Cleared Sep 02, 1998
VOLUMAX CT IMAGING SYSTEM
K982060 · JAK
Elscint, Inc.
Radiology · 83d
Cleared Jun 03, 1998
CT SCOPE
K974344 · JAK
Elscint, Inc.
Radiology · 196d
Cleared Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
K980306 · LNH
Elscint, Inc.
Radiology · 65d
Cleared Mar 04, 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA...
K974614 · LNH
Elscint, Inc.
Radiology · 83d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · MOS
Elscint, Inc.
Radiology · 66d
Cleared Jun 20, 1997
GLORY
K970680 · IZH
Elscint, Inc.
Radiology · 116d
Cleared Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO....
K965044 · LNH
Elscint, Inc.
Radiology · 185d
Cleared May 29, 1997
CARDIAC SCORING FOR CT SCANNERS
K970980 · JAK
Elscint, Inc.
Radiology · 72d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005 · LNI
Elscint, Inc.
Radiology · 85d
Cleared Jan 17, 1997
XRT-7.0
K964583 · JAK
Elscint, Inc.
Radiology · 63d
Cleared Jan 10, 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · KPS
Elscint, Inc.
Radiology · 225d
Cleared Nov 12, 1996
QUANTEM
K963162 · KPS
Elscint, Inc.
Radiology · 90d
Cleared Sep 04, 1996
GYREX V-EP
K962618 · LNH
Elscint, Inc.
Radiology · 63d
Cleared Jul 03, 1996
SELECT/SP
K961464 · JAK
Elscint, Inc.
Radiology · 77d
Cleared Jun 12, 1996
ESI-5000
K935024 · IYN
Elscint, Inc.
Radiology · 966d
Cleared Apr 29, 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · IZH
Elscint, Inc.
Radiology · 94d
Cleared Nov 24, 1995
GYREX PRIVILEGE
K954039 · LNH
Elscint, Inc.
Radiology · 88d
Cleared Nov 22, 1995
VARICAM
K953801 · KPS
Elscint, Inc.
Radiology · 103d
Cleared Sep 26, 1995
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
K952674 · KPS
Elscint, Inc.
Radiology · 106d
Cleared Sep 19, 1995
GYRES 2T PRESTIGE
K945791 · LNH
Elscint, Inc.
Radiology · 298d
Cleared Mar 31, 1995
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353 · IZH
Elscint, Inc.
Radiology · 375d
Cleared Mar 14, 1995
HRSW OPTION FOR CT TWIN FLASH
K945512 · JAK
Elscint, Inc.
Radiology · 125d
Cleared Nov 29, 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
K943320 · LNH
Elscint, Inc.
Radiology · 141d