Atlas FDA

INNOVA 4100, INNOVA 3100

FDA 510(k) clearance K042053 · decided 2004-08-26

Clearance details

K-number
K042053
Device name
INNOVA 4100, INNOVA 3100
Applicant
Ge Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2004-07-30
Decision date
2004-08-26
Days to decision
27 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, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging Syste recall (Z-1616-2013)GE Healthcare, LLC2013-06-28
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 recall (Z-1318-2013)GE Healthcare, LLC2013-05-14
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventio recall (Z-1142-2013)GE Healthcare, LLC2013-04-18
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and recall (Z-0947-2013)GE Healthcare, LLC2013-03-13
GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicate recall (Z-0133-2012)GE Healthcare, LLC2011-10-28
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
GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consis recall (Z-0135-2010)GE Medical Systems, LLC2009-11-09
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
Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, recall (Z-2241-2009)GE Medical Systems, LLC2009-09-24
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 (The syst recall (Z-2242-2009)GE Medical Systems, LLC2009-09-24
GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. recall (Z-1475-2009)GE Medical Systems, LLC2009-06-19
GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. recall (Z-1476-2009)GE Medical Systems, LLC2009-06-19
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-1092-2009)GE Medical Systems, LLC2009-03-12
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 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-0474-2009)GE Medical Systems, LLC2009-01-21
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 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) recall (Z-1521-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option. recall (Z-1516-2008)GE Healthcare2008-09-29
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option. recall (Z-1517-2008)GE Healthcare2008-09-29
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-2356-2008)GE Healthcare2008-09-21
GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an recall (Z-2358-2008)GE Healthcare2008-09-21
Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (T recall (Z-2437-2008)GE Healthcare2008-09-20
Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a mon recall (Z-2438-2008)GE Healthcare2008-09-20
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-0691-2008)GE Healthcare2008-01-31
GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an recall (Z-0692-2008)GE Healthcare2008-01-31
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-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

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