Ge Healthcare

FDA Filings

This page includes the latest FDA filings for Ge Healthcare. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Ge Healthcare holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2915056
FEI Number1417338
NameGE HEALTHCARE
Owner & OperatorGE Healthcare Inc.- Life Sciences
Contact Address100 Results Way
Marlborough MA 01752 US
Official Correspondent
  • Alletah Schmidt
  • 001-774-2496290-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3350 N RIDGE AVE
ARLINGTON HEIGHTS, IL 60004 US
Establishment TypeRepack or Relabel Medical Device



Registration Number3004526608
FEI Number3004526608
NameGE HEALTHCARE
Owner & OperatorGENERAL ELECTRIC CO.
Contact Address3000 N. Grandview Blvd W-440
Waukesha WI 53188 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address500 W. Monroe Street
Chicago, IL 60661 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Owner/Operator Registration




FDA Filings

Device
Company
DeviceDate
GE Healthcare
Pristina Serena Bright2020-05-15
GE Healthcare
CARESCAPE ONE And CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES2020-03-29
GE Healthcare, GE Healthcare AS, GE Healthcare Lindesnes
Prescription Medication2020-02-19
GE HEALTHCARE
Centricity 2020-02-14
GE HEALTHCARE
CENTRICITY 2020-02-04
GE HEALTHCARE
Centricity 2020-02-04
GE HEALTHCARE
Centricity 2020-02-04
GE HEALTHCARE
CA1000 2020-02-04
GE HEALTHCARE
Centricity 2020-02-04
GE HEALTHCARE
Centricity 2020-02-04
GE HEALTHCARE
Centricity 2020-02-04
GE HEALTHCARE
Centricity 2020-02-04
GE HEALTHCARE
CENTRICITY 2020-02-04
GE HEALTHCARE
CENTRICITY 2020-02-04
GE HEALTHCARE
CENTRICITY 2020-02-04
GE Healthcare
Carescape One2019-12-20
GE Healthcare, GE Healthcare AS, GE Healthcare Lindesnes
Prescription Medication2019-11-08
GE Healthcare
CLARISCAN2019-11-01
GE Healthcare
Voluson E6, Voluson E8, Voluson E102019-08-29
GE Healthcare
Sample Imaging For Senographe Pristina2019-07-29
GE Healthcare
Pristina Serena 3D2019-01-18
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Universal Viewer2019-01-10
GE Healthcare
Centricity Universal Viewer2018-12-14
GE Healthcare
Unity Network ID2018-12-06
GE Healthcare
Voluson E6, Voluson E8, Voluson E102018-11-15
GE Healthcare, GE Healthcare Ireland Limited, GE Healthcare Lindesnes, GE Healthcare Shanghai Co., Ltd.
Prescription Medication2018-11-14
GE Healthcare, GE Healthcare Ireland Limited, GE Healthcare Lindesnes, GE Healthcare Shanghai Co., Ltd.
Prescription Medication2018-11-08
GE Healthcare
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR2018-11-02
GE Healthcare
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA2018-10-19
GE Healthcare
LOGIQ P9; LOGIQ P72018-09-20
GE Healthcare
Pristina Serena2018-05-14
GE Healthcare
Invenia ABUS Viewer2018-05-04
GE Healthcare
NM/CT 850, NM/CT 8602018-04-17
GE Healthcare
Voluson P6 And Voluson P82018-03-29
GE Healthcare
Voluson S8/ Voluson S10/ Voluson S10 Expert2018-03-13
GE Healthcare
Senographe Pristina 3D2017-12-28
GE Healthcare
LOGIQ E102017-12-20
GE Healthcare
SenoBright HD2017-10-30
GE Healthcare
Voluson E6, Voluson E8, Voluson E102017-09-29
GE Healthcare
Senographe Pristina2017-09-01
GE Healthcare
Unity Network ID2017-05-12
GE Healthcare
LOGIQ S82017-04-11
GE Healthcare
SENOGRAPHE PRISTINA 3D2017-03-03
GE HEALTHCARE
LOGIQ P9 And LOGIQ P72017-02-10
GE Healthcare
SENOCLAIRE2017-01-05
GE Healthcare
Omnipaque2016-12-21
GE Healthcare
Omnipaque2016-12-21
GE Healthcare
Discovery NM 750b Bopsy2016-11-18
GE HEALTHCARE
Senographe Pristina2016-11-03
GE Healthcare
Voluson E6, Voluson E8, Voluson E102016-10-03
GE HEALTHCARE
CARESCAPE Central Station V22016-09-15
GE HEALTHCARE
SIGNA Voyager2016-09-01
GE Healthcare
Senolris2016-08-01
GE Healthcare
LOGIQ P9 And LOGIQ P72016-05-05
GE HEALTHCARE
Voluson P6, Voluson P82016-04-26
GE HEALTHCARE
SIGNAPioneer2016-03-29
GE HEALTHCARE
Xeleris 4.0 Processing And Review Workstation2016-03-16
GE Healthcare
LOGIQ S7 Expert2016-02-26
GE HEALTHCARE
Voluson S6, Voluson S8, Voluson S102016-02-25
GE HEALTHCARE
Discovery NM/CT 670 CZT2016-01-21
GE HEALTHCARE [GE Healthcare Inc.- Life Sciences]
DaTQUANT2015-12-16
GE Healthcare
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System2015-11-06
GE HEALTHCARE
SIGNA Pioneer2015-10-27
GE Healthcare
LOGIQ S82015-09-29
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Universal Viewer2015-05-27
GE HEALTHCARE
Centricity Universal Viewer2015-05-26
GE HEALTHCARE
Mammo Workstation2015-03-26
GE Healthcare
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems2015-02-10
GE HEALTHCARE
LOGIQ P9, LOGIQ P72015-01-29
GE HEALTHCARE
Unity Network ID2015-01-07
GE HEALTHCARE
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM2014-10-10
GE Healthcare
SENOCLAIRE2014-08-26
GE HEALTHCARE
LOGIQ V5/LOGIQ V32014-08-04
GE HEALTHCARE
VOLUSON P6, VOLUSON P82014-07-25
GE HEALTHCARE
VOLUSON S6, VOLUSON S82014-07-18
GE HEALTHCARE
LOGIQ S7 EXPERT, LOGIQ S7 PRO2014-06-05
GE HEALTHCARE
VIVID T8/VIVID T8 PRO2014-05-23
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Radiology Mobile Access2014-04-07
GE HEALTHCARE
LOGIQ E2014-02-12
GE HEALTHCARE
LOGIQ F SERIES2014-01-31
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Universal Viewer Zero Footprint2014-01-22
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Universal Viewer Zero Footprint client2014-01-22
GE HEALTHCARE
VENUE 502013-12-24
GE HEALTHCARE
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E102013-11-08
GE HEALTHCARE
VOLUSON I/E2013-09-24
GE HEALTHCARE
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT2013-09-17
GE HEALTHCARE
LOGIQ S82013-08-26
GE HEALTHCARE
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E102013-06-19
GE HEALTHCARE
4D VIEW2013-05-16
GE HEALTHCARE
INNOVA EPVISION 2.0, INNOVA EPVISION 2.02013-04-05
GE HEALTHCARE
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS2013-01-02
GE HEALTHCARE
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM2012-12-18
GE HEALTHCARE [GENERAL ELECTRIC CO.]
PACS-IW with Universal Viewer2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Perinatal2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Perinatal and Centricity Intensive Care2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Perinatal2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Perinatal and Centricity Intensive Care2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS (RA1000)2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS2012-11-21
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS (RA1000)2012-11-21
GE HEALTHCARE
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER2012-11-16
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS IW2012-11-13
GE HEALTHCARE
FLIGHTPLAN FOR LIVER2012-11-02
GE HEALTHCARE
C1-6-D ULTRASOUND TRANSDUCER2012-10-05
GE HEALTHCARE
LOGIQ S7 EXPERT, LOGIQ S7 PRO2012-10-03
GE HEALTHCARE
VOLUSON E6/E8/E8EXPERT/E102012-09-21
GE HEALTHCARE
C2-9-D ULTRASOUND TRANSDUCER2012-09-11
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Cardio Imaging2012-02-24
GE Healthcare
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2010-11-05
GE Healthcare
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2010-05-27
GE Healthcare
GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM2010-05-20
GE Healthcare
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2009-11-24
GE Healthcare
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2009-07-10
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS Web Diagnostic2009-03-17
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity PACS IW2009-03-17
GE HEALTHCARE [GENERAL ELECTRIC CO.]
INTEGRADWEB PACS SYSTEM2009-03-17
GE Healthcare
GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM2008-07-30
GE Healthcare
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2008-07-16
GE Healthcare
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2008-05-27
GE Healthcare
Prescription Medication2007-10-17
GE Healthcare
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL2007-08-01
GE Healthcare
SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS2007-04-13
GE Healthcare
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2007-04-13
GE Healthcare
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS2007-01-03
GE Healthcare
SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS2006-10-20
GE Healthcare
SENOGRAPHE ESSENTIAL SYSTEM2006-09-01
GE Healthcare
SENOGRAPHE DS FFDM SYSTEM2006-05-05
GE Healthcare
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2006-04-11
GE Healthcare
SENOGRAPHE DS & 2000D FFDM SYSTEM2005-10-17
GE Healthcare
SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2005-07-01
GE Healthcare
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2005-05-25
GE Healthcare
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2004-06-07
GE Healthcare
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2004-02-19
GE Healthcare
SENOGRAPHE2002-11-21
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2002-06-13
GE Healthcare
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2002-06-05
GE Healthcare
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2002-06-05
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2002-04-12
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM2002-04-03
GE Healthcare
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2002-02-22
GE Healthcare
MOBILE SENOGRAPHE 2000D2001-12-18
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2001-12-06
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2001-12-03
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2001-10-01
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2001-09-12
GE Healthcare
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2001-04-24
GE Healthcare
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2001-01-08
GE Healthcare
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2000-11-13
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Radiology RA600, Centricity Cardiology CA 1000, and Digital Hardcopy2000-03-06
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity Radiology RA600 / Centricity Cardiology CA1000 / DHC2000-03-06
GE HEALTHCARE [GENERAL ELECTRIC CO.]
Centricity AW Suite2000-03-06
GE Healthcare
GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2000-01-28

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