Atlas FDA

INNOVA 4100

FDA 510(k) clearance K023178 · decided 2002-11-26

Clearance details

K-number
K023178
Device name
INNOVA 4100
Applicant
Ge Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2002-09-23
Decision date
2002-11-26
Days to decision
64 days
Clearance type
Traditional
Product code
OWB
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innov recall (Z-1163-2014)GE Healthcare, LLC2014-03-10
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 410 recall (Z-0021-2014)GE Healthcare, LLC2013-10-17
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and recall (Z-0947-2013)GE Healthcare, LLC2013-03-13
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The sys recall (Z-0392-2011)GE Healthcare, LLC2010-11-16
Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscop recall (Z-1921-2010)Ge Healthcare, Llc2010-06-29
Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluo recall (Z-1922-2010)Ge Healthcare, Llc2010-06-29
Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating fluor recall (Z-1923-2010)Ge Healthcare, Llc2010-06-29
Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray syst recall (Z-0619-2010)GE Medical Systems, LLC2010-01-13
GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positio recall (Z-0137-2010)GE Medical Systems, LLC2009-11-09
GE Innova 4100, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane recall (Z-1690-2009)Ge Healthcare2009-09-24
GE Innova 4100-IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monopla recall (Z-1691-2009)Ge Healthcare2009-09-24
GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. recall (Z-1476-2009)GE Medical Systems, LLC2009-06-19
Innova 4100 / 4100 IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a mon recall (Z-1093-2009)GE Medical Systems, LLC2009-03-12
GE Innova 4100 /4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a recall (Z-0475-2009)GE Medical Systems, LLC2009-01-21
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System recall (Z-1522-2008)Datex - Ohmeda, Inc2008-09-30
GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an recall (Z-2358-2008)GE Healthcare2008-09-21
Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a mon recall (Z-2438-2008)GE Healthcare2008-09-20
Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascula recall (Z-2041-2008)GE Healthcare2008-09-16
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and va recall (Z-1043-2007)General Electric Med Systems LLC2007-07-10
GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Ima recall (Z-1044-2007)General Electric Med Systems LLC2007-07-10
GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiograp recall (Z-0915-2007)General Electric Med Systems LLC2007-06-09
GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiograp recall (Z-0869-2007)General Electric Med Systems LLC2007-06-05
GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Ima recall (Z-0870-2007)General Electric Med Systems LLC2007-06-05
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and va recall (Z-0871-2007)General Electric Med Systems LLC2007-06-05
GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital recall (Z-0898-06)GE Healthcare2006-05-24

PMA approvals by this applicant

RecordFirmDate
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011)Ge Medical Systems, Inc.2012-10-10
FETAL ACOUSTIC STIMULATOR (P870025/S010)Ge Medical Systems, Inc.2011-10-12
FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009)Ge Medical Systems, Inc.2010-04-23
FETAL ACOUSTIC STIMULATOR (P870025/S008)Ge Medical Systems, Inc.2006-03-02
COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007)Ge Medical Systems, Inc.2005-03-24
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006)Ge Medical Systems, Inc.2001-11-09
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005)Ge Medical Systems, Inc.1996-07-17
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004)Ge Medical Systems, Inc.1996-02-01