Atlas FDA

GE Healthcare

55 FDA 510(k) clearances · PMA applicant

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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
SENOGRAPHE PRISTINA 3D (P130020/S002)GE Healthcare2017-03-03
SENOCLAIRE (P130020/S001)GE Healthcare2017-01-05
INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S006)GE Healthcare2015-10-15
INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S005)GE Healthcare2015-04-13
INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S004)GE Healthcare2014-11-24
SENOCLAIRE (P130020)GE Healthcare2014-08-26
INVENIA ABUS (P110006/S003)GE Healthcare2014-03-20
INVENIA ABUS (P110006/S002)GE Healthcare2014-02-11
SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S001)GE Healthcare2013-06-17
SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) (P110006)GE Healthcare2012-09-18
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S037)GE Healthcare2010-11-05
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S036)GE Healthcare2010-05-27
GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM (P990066/S035)GE Healthcare2010-05-20
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S034)GE Healthcare2009-11-24
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S033)GE Healthcare2009-07-10
GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM (P990066/S032)GE Healthcare2008-07-30
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S031)GE Healthcare2008-07-16
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S030)GE Healthcare2008-05-27
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL (P990066/S029)GE Healthcare2007-08-01
SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS (P990066/S028)GE Healthcare2007-04-13
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S027)GE Healthcare2007-04-13
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS (P990066/S026)GE Healthcare2007-01-03
SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS (P990066/S025)GE Healthcare2006-10-20
SENOGRAPHE ESSENTIAL SYSTEM (P990066/S024)GE Healthcare2006-09-01
SENOGRAPHE DS FFDM SYSTEM (P990066/S023)GE Healthcare2006-05-05
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S021)GE Healthcare2006-04-11
SENOGRAPHE DS & 2000D FFDM SYSTEM (P990066/S022)GE Healthcare2005-10-17
SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S020)GE Healthcare2005-07-01
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S019)GE Healthcare2005-05-25
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S017)GE Healthcare2004-06-07
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S016)GE Healthcare2004-02-19
SENOGRAPHE (P990066/S015)GE Healthcare2002-11-21
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S014)GE Healthcare2002-06-13
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S009)GE Healthcare2002-06-05
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S013)GE Healthcare2002-06-05
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S007)GE Healthcare2002-04-12
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM (P990066/S012)GE Healthcare2002-04-03
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S011)GE Healthcare2002-02-22
MOBILE SENOGRAPHE 2000D (P990066/S008)GE Healthcare2001-12-18
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S004)GE Healthcare2001-12-06
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S010)GE Healthcare2001-12-03
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S006)GE Healthcare2001-10-01
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S005)GE Healthcare2001-09-12
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S003)GE Healthcare2001-04-24
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S002)GE Healthcare2001-01-08
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S001)GE Healthcare2000-11-13
GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066)GE Healthcare2000-01-28

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Every clearance here is in the API, with alerts when new ones post.