Atlas FDA

INNOVA 2100

FDA 510(k) clearance K050489 · decided 2005-03-11

Clearance details

K-number
K050489
Device name
INNOVA 2100
Applicant
Ge Medical Systems, LLC
Decision
Substantially Equivalent
Date received
2005-02-25
Decision date
2005-03-11
Days to decision
14 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
Yes
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 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 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imagin recall (Z-0934-2013)GE Healthcare, LLC2013-03-11
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane position recall (Z-0408-2011)GE Healthcare, LLC2010-11-17
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, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a mon recall (Z-1661-2010)Ge Healthcare, Llc2010-05-26
Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System recall (Z-0617-2010)GE Medical Systems, LLC2010-01-13
GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The syste recall (Z-0136-2010)GE Medical Systems, LLC2009-11-09
GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, recall (Z-1474-2009)GE Medical Systems, LLC2009-06-19
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-0473-2009)GE Medical Systems, LLC2009-01-21
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Va recall (Z-1518-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging s recall (Z-1519-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography sys recall (Z-1520-2008)Datex - Ohmeda, Inc2008-09-30
Innova 2000 The principle system components include a C-arm, image acquisition, processing recall (Z-2361-2008)GE Healthcare2008-09-21
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane position recall (Z-2436-2008)GE Healthcare2008-09-20
Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane pos recall (Z-2039-2008)GE Healthcare2008-09-16
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-0690-2008)GE Healthcare2008-01-31
GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imag recall (Z-1088-2007)GE Healthcare2007-09-28
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