Atlas FDA

INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ

FDA 510(k) clearance K052412 · decided 2005-09-16

Clearance details

K-number
K052412
Device name
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2005-09-02
Decision date
2005-09-16
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
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vas recall (Z-0453-2015)GE Healthcare, LLC2014-12-16
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, 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 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicate recall (Z-0133-2012)GE Healthcare, LLC2011-10-28
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
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
GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a recall (Z-1036-2009)GE Medical Systems, LLC2009-09-24
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
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
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
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-2356-2008)GE Healthcare2008-09-21
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-2357-2008)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 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane position recall (Z-2436-2008)GE Healthcare2008-09-20
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
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
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 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and va recall (Z-0913-2007)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

PMA approvals by this applicant

RecordFirmDate
Senographe Pristina 3D (P130020/S005)GE Healthcare2025-11-21
Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011)GE Healthcare2025-02-04
Senographe Pristina 3D and SenoClaire (P130020/S004)GE Healthcare2021-03-23
Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010)GE Healthcare2018-08-24
Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009)GE Healthcare2018-05-11
Senographe Pristina 3D (P130020/S003)GE Healthcare2017-12-28
Invenia ABUS Autoated Breast Ultrasound System (P110006/S008)GE Healthcare2017-09-07
Invenia ABUS - Automated Breast Ultrasound System (P110006/S007)GE Healthcare2017-05-01