Atlas FDA

INNOVA 3100

FDA 510(k) clearance K031637 · decided 2003-08-22

Clearance details

K-number
K031637
Device name
INNOVA 3100
Applicant
GE Medical Systems
Decision
Substantially Equivalent
Date received
2003-05-27
Decision date
2003-08-22
Days to decision
87 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, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and recall (Z-0947-2013)GE Healthcare, LLC2013-03-13
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 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascu recall (Z-0618-2010)GE Medical Systems, LLC2010-01-13
GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consis recall (Z-0135-2010)GE Medical Systems, LLC2009-11-09
GE Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The syst recall (Z-1688-2009)Ge Healthcare2009-09-24
GE Innova 3100-IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The s recall (Z-1689-2009)Ge Healthcare2009-09-24
Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, recall (Z-2241-2009)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 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-1092-2009)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 Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) recall (Z-1521-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System recall (Z-1522-2008)Datex - Ohmeda, Inc2008-09-30
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-2356-2008)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 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monopla recall (Z-2040-2008)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 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Ima recall (Z-0914-2007)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 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiov recall (Z-0897-06)GE Healthcare2006-05-24