Atlas FDA

INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT

FDA 510(k) clearance K061163 · decided 2006-06-07

Clearance details

K-number
K061163
Device name
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
Applicant
Ge Medical Systems, LLC
Decision
Substantially Equivalent
Date received
2006-04-26
Decision date
2006-06-07
Days to decision
42 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 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 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imagin recall (Z-0934-2013)GE Healthcare, LLC2013-03-11
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: recall (Z-2376-2012)GE Healthcare, LLC2012-09-13
GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicate recall (Z-0133-2012)GE Healthcare, LLC2011-10-28
Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems recall (Z-0407-2011)GE Healthcare, LLC2010-11-17
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane position recall (Z-0408-2011)GE Healthcare, LLC2010-11-17
Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, recall (Z-0409-2011)GE Healthcare, LLC2010-11-17
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The sys recall (Z-0410-2011)GE Healthcare, LLC2010-11-17
GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (T recall (Z-1659-2010)Ge Healthcare, Llc2010-05-26
GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, ( recall (Z-1660-2010)Ge Healthcare, Llc2010-05-26
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
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
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
Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging S recall (Z-0621-2010)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 Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The syste recall (Z-0136-2010)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 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. recall (Z-0138-2010)GE Medical Systems, LLC2009-11-09
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-1687-2009)Ge Healthcare2009-09-24
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
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 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, recall (Z-1474-2009)GE Medical Systems, LLC2009-06-19
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
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems a recall (Z-1195-2009)GE Medical Systems, LLC2009-05-19
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-0473-2009)GE Medical Systems, LLC2009-01-21
GE 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
Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems a recall (Z-2360-2008)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 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane pos recall (Z-2039-2008)GE Healthcare2008-09-16
Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monopla recall (Z-2040-2008)GE Healthcare2008-09-16
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
Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane syst recall (Z-2043-2008)GE Healthcare2008-09-16