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Radiology

435 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM (P030010/S005)Siemens Medical Solution2010-10-06
HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM (P010025/S020)Hologic, Inc.2010-09-07
ONGUARD (P000041/S009)Riverain Medical Group2010-06-10
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
SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S018)Hologic, Inc.2010-03-04
SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S017)Hologic, Inc.2009-12-23
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S034)GE Healthcare2009-11-24
FULL FIELD DIGITAL MAMMOGRAPHY (P050014/S002)Fujifilm Medical System U.S.A., Inc.2009-08-11
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S033)GE Healthcare2009-07-10
MAMMOMAT NOVATION DR (P030010/S004)Siemens Medical Solution2009-06-04
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S016)Hologic, Inc.2009-05-01
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S015)Hologic, Inc.2009-03-16
FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (P050014/S001)Fujifilm Medical System U.S.A., Inc.2009-01-09
SELENIA DIMENSIONS (2D) FFDM SYSTEM (P010025/S013)Hologic, Inc.2008-12-22
SECONDLOOK (SL) CAD (P010038/S015)Icad, Inc.2008-10-09
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
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S012)Hologic, Inc.2008-05-23
SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM (P010038/S012)Icad, Inc.2008-04-04
SIR-SPHERES (P990065/S004)Sirtex Medical, Inc.2008-01-18
ONGUARD (P000041/S006)Riverain Medical Group2007-08-30
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL (P990066/S029)GE Healthcare2007-08-01
SECONDLOOK (P010038/S014)Icad, Inc.2007-07-27
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S010)Hologic, Inc.2007-06-01
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
KODAK MAMMOGRAPHY CAD ENGINE (P030007/S003)Carestream Health, Inc.2007-03-23
IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY (P970058/S024)Hologic, Inc.2007-02-09
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S009)Hologic, Inc.2007-01-17
LOGICON CARIES DETECTOR (P980025/S001)Carestream Dental, LLC2007-01-12
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS (P990066/S026)GE Healthcare2007-01-03
RAPIDSCREEN RS-2000D (P000041/S005)Riverain Medical Group2006-11-01
SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS (P990066/S025)GE Healthcare2006-10-20
SYNGO LUNG CAD (P050022)Siemens Medical Solutions USA, Inc.2006-10-18
SENOGRAPHE ESSENTIAL SYSTEM (P990066/S024)GE Healthcare2006-09-01
RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL (P000041/S003)Riverain Medical Group2006-07-27
FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS) (P050014)Fujifilm Medical System U.S.A., Inc.2006-07-10
IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY (P970058/S022)Hologic, Inc.2006-06-23
SENOGRAPHE DS FFDM SYSTEM (P990066/S023)GE Healthcare2006-05-05
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S021)GE Healthcare2006-04-11
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S008)Hologic, Inc.2006-03-29
SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM (P030010/S003)Siemens Medical Solution2006-02-15
FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017/S007)Hologic, Inc.2006-02-13
SECOND LOOK (P010038/S010)Icad, Inc.2006-01-13
CERALAS I LASER (P050021)Biolitec, Inc.2005-12-20
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S007)Hologic, Inc.2005-10-31
SENOGRAPHE DS & 2000D FFDM SYSTEM (P990066/S022)GE Healthcare2005-10-17
MAMMOGRAPHY CAD ENGINE (P030007/S001)Carestream Health, Inc.2005-09-16
SIEMENS MAMMOMAT NOVATION FFDM SYSTEM (P030010/S001)Siemens Medical Solution2005-07-07
SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S020)GE Healthcare2005-07-01
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S002)Siemens Medical Solution2005-06-20
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S019)GE Healthcare2005-05-25
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM (P010038/S009)Icad, Inc.2005-03-07
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017/S005)Hologic, Inc.2005-03-07
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S005)Hologic, Inc.2005-02-18
IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0 (P970058/S020)Hologic, Inc.2005-02-17
IMAGECHECKER D (P970058/S021)Hologic, Inc.2005-01-05
KODAK MAMMOGRAPHY CAD ENGINE (P030007)Carestream Health, Inc.2004-11-23
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM (P010038/S008)Icad, Inc.2004-09-01
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010)Siemens Medical Solution2004-08-20
ACHILLES EXPRESS ULTRASONOMETER (P970040/S003)Ge Lunar Corp.2004-07-30
IMAGECHECKER CT CAD SOFTWARE SYSTEM (P030012)Hologic, Inc.2004-07-08
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S017)GE Healthcare2004-06-07
ICAD SYSTEM (P010038/S006)Icad, Inc.2004-05-21
ICAD SYSTEM (P010038/S007)Icad, Inc.2004-05-19
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017/S004)Hologic, Inc.2004-05-12
IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2) (P970058/S019)Hologic, Inc.2004-04-07
OSTEOSPACE (P010058)Medilink2004-03-15
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S004)Hologic, Inc.2004-03-02
SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S016)GE Healthcare2004-02-19
BSD-500 HYPERTHERMIA SYSTEM (P820088/S017)Pyrexar Medical, Inc.2004-01-20
IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1) (P970058/S018)Hologic, Inc.2003-11-26
IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0) (P970058/S017)Hologic, Inc.2003-11-25
OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S005)Beam-Med, Ltd.2003-11-17
ICAD SYSTEM (P010038/S005)Icad, Inc.2003-10-31
SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY (P010034/S004)Icad, Inc.2003-10-31
ICAD SYSTEM (P010038/S004)Icad, Inc.2003-10-10
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S003)Hologic, Inc.2003-10-10
BSD-500 HYPERTHERMIA SYSTEM (P820088/S016)Pyrexar Medical, Inc.2003-10-08
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY (P010034/S005)Icad, Inc.2003-10-08
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S002)Hologic, Inc.2003-09-24
IMAGE CHECKER M1000 SYSTEM (P970058/S016)Hologic, Inc.2003-09-10
SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY (P010034/S003)Icad, Inc.2003-08-11
RAPIDSCREEN RS-2000D (P000041/S002)Riverain Medical Group2003-08-08
RAPIDSCREEN RS-2000D (P000041/S001)Riverain Medical Group2003-06-30
QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001)Quidel Corp.2003-06-19
SUNLIGHT OMNISENSE BONE SONOMETER (P990035/S006)Beam-Med, Ltd.2003-04-24
SIR-SPHERES (P990065/S001)Sirtex Medical, Inc.2003-04-24
SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY (P010034/S002)Icad, Inc.2003-03-07
ICAD (P010038/S003)Icad, Inc.2003-03-06
IMAGECHECKER (P970058/S015)Hologic, Inc.2003-03-04
ICAD (P010038/S001)Icad, Inc.2003-02-24
SENOGRAPHE (P990066/S015)GE Healthcare2002-11-21
ICAD (P010038/S002)Icad, Inc.2002-11-20
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S001)Hologic, Inc.2002-10-02
IMAGECHECKER M1000 SYSTEM (P970058/S014)Hologic, Inc.2002-09-13
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
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Every clearance here is in the API, with alerts when new ones post.