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Radiology

435 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S013)GE Healthcare2002-06-05
SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S003)Beam-Med, Ltd.2002-05-24
SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY (P010034/S001)Icad, Inc.2002-05-07
IMAGE CHECKER M1000 SYSTEM (P970058/S013)Hologic, Inc.2002-04-24
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
MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM (P990016/S002)CooperSurgical, Inc.2002-03-28
LORAD DIGITAL BREAST IMAGER (P010025)Hologic, Inc.2002-03-15
SIR-SPHERES (P990065)Sirtex Medical, Inc.2002-03-05
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S011)GE Healthcare2002-02-22
IMAGECHECKER M1000 (P970058/S012)Hologic, Inc.2002-02-11
SECOND LOOK (TM) (P010034)Icad, Inc.2002-01-31
SECOND LOOK (P010038)Icad, Inc.2002-01-15
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
SUNLIGHT OMNISENSE 7000S (P990035/S004)Beam-Med, Ltd.2001-11-30
IMAGE CHECKER (CAD) SYSTEM, M100 (P970058/S011)Hologic, Inc.2001-11-13
MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM (P990016/S001)CooperSurgical, Inc.2001-11-08
ACHILLES INSIGHT ULTRASONOMETER (P970040/S002)Ge Lunar Corp.2001-10-24
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S006)GE Healthcare2001-10-01
SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017)Hologic, Inc.2001-09-25
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S005)GE Healthcare2001-09-12
SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER (P990035/S002)Beam-Med, Ltd.2001-07-27
UBIS 5000 BONE SONOMETER (P000055)Diagnostic Medical Systems2001-07-17
RAPIDSCREEN RS-2000 (P000041)Riverain Medical Group2001-07-12
OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S001)Beam-Med, Ltd.2001-06-21
IMAGE CHECKER (CAD) SYSTEM, M1000 (P970058/S010)Hologic, Inc.2001-05-29
SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S003)GE Healthcare2001-04-24
PROMINENT CALC FEATURE MARKER (P970058/S009)Hologic, Inc.2001-01-22
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
DTU-ONE ULTRASOUND SCANNER (P980010)Osteometer Meditech A/S2000-09-19
QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039)Quidel Corp.2000-08-01
IMAGE CHECKER M1000 SYSTEM (P970058/S008)Hologic, Inc.2000-07-05
IMAGECHECKER M1000 SYSTEM (P970058/S007)Hologic, Inc.2000-05-16
TRANSCAN T-SCAN 2000 (P970033/S002)Mirabel Medical Systems, Inc.2000-05-03
IMAGECHECKER M1000 SYSTEM (P970058/S006)Hologic, Inc.2000-04-17
GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066)GE Healthcare2000-01-28
THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER (P990035)Beam-Med, Ltd.2000-01-20
MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 (P990016)CooperSurgical, Inc.2000-01-07
TS2000 (P970033/S001)Mirabel Medical Systems, Inc.1999-11-15
IMAGE CHECKER M1000 (P970058/S005)Hologic, Inc.1999-10-05
THE IMAGECHECKER SYSTEM (P970058/S004)Hologic, Inc.1999-09-02
HOLOGIC SAHARA CLINICAL BONE SONOMETER (P970017/S001)Hologic, Inc.1999-04-29
ACHILLES EXPRESS ULTRASONOMETER (P970040/S001)Ge Lunar Corp.1999-04-23
T-SCAN 2000 (P970033)Mirabel Medical Systems, Inc.1999-04-16
IMAGE CHECKER (P970058/S003)Hologic, Inc.1999-02-10
IMAGECHECKER M1000 SYSTEM (P970058/S002)Hologic, Inc.1999-01-16
IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE (P970058/S001)Hologic, Inc.1998-10-21
LOGICON CARIES DETECTOR (P980025)Carestream Dental, LLC1998-09-25
HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD (P940005/S002)Advanced Technology Laboratories, Inc.1998-07-21
ACHILLES EXPRESS ULTRASONOMETER (P970040)Ge Lunar Corp.1998-06-26
M1000 IMAGECHECKER (P970058)Hologic, Inc.1998-06-26
MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN (P970026)Myriad Ultrasound Systems , Ltd.1998-05-29
SAHARA CLINICAL BONE SONOMETER (P970017)Hologic, Inc.1998-03-12
HYPERTHERMIA SYSTEM 100 A (P880064/S002)Medifocus, Inc.1997-09-17
ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED (P900059/S004)Molecular Biosystems, Inc.1997-06-17
SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM (P880062/S002)Labthermics Technologies, Inc.1997-02-13
HDI 3000 ULTRASOUND SYSTEM (P940005/S001)Advanced Technology Laboratories, Inc.1996-12-23
ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM (P940005)Advanced Technology Laboratories, Inc.1996-04-11
ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S002)Molecular Biosystems, Inc.1996-03-01
ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S003)Molecular Biosystems, Inc.1995-08-28
ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S001)Molecular Biosystems, Inc.1995-07-31
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S011)Cook, Inc.1994-01-26
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S010)Cook, Inc.1993-05-21
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S009)Cook, Inc.1992-08-31
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S008)Cook, Inc.1992-05-21
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S007)Cook, Inc.1992-05-21
VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500 (P880078/S006)Cook, Inc.1992-02-25
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S014)Pyrexar Medical, Inc.1991-11-26
VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500 (P880078/S005)Cook, Inc.1991-10-28
VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500 (P880078/S001)Cook, Inc.1991-09-20
VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500 (P880078/S002)Cook, Inc.1991-05-02
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S008)Pyrexar Medical, Inc.1991-03-28
VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500 (P880078/S004)Cook, Inc.1990-10-17
SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM (P880062/S001)Labthermics Technologies, Inc.1990-08-23
CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR (P840015/S014)Clini-Therm Corp.1990-07-17
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S011)Pyrexar Medical, Inc.1990-06-21
HYPERTHERMIA SYSTEM 100 A (P880064)Medifocus, Inc.1989-11-17
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078)Cook, Inc.1989-10-17
SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM (P880062)Labthermics Technologies, Inc.1989-09-29
CLINI-THERM MARK I/IV (P840015/S013)Clini-Therm Corp.1988-12-15
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S006)Pyrexar Medical, Inc.1988-12-13
CLINI-THERM MARK I/IV (P840015/S012)Clini-Therm Corp.1988-08-22
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017)General Electric Co.1988-07-29
DIASONICS NMR IMAGING SYSTEM (P830053/S030)Diasonics, Inc.1988-07-27
RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST (P860062/S002)Resonex, Inc.1988-07-27
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019)Philips Medical Systems (Cleveland), Inc.1988-07-27
MAGNETOM (P830081/S022)Siemens Corp.1988-07-25
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013)General Electric Co.1988-07-15
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022)Philips Medical Systems (Cleveland), Inc.1988-07-14
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S015)Technicare Corp.1988-07-14
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021)Philips Medical Systems (Cleveland), Inc.1988-07-14
FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S012)Fonar Corp.1988-07-12
MAGNETOM (P830081/S019)Siemens Corp.1988-07-12
DIASONICS NMR IMAGING SYSTEM (P830053/S029)Diasonics, Inc.1988-07-07
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016)General Electric Co.1988-06-30
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018)Philips Medical Systems (Cleveland), Inc.1988-06-13
INSTRUMENTARIUM ULF MR IMAGING SYSTEM (P860010/S003)Palomex Instrumentarium Corp.1988-06-12
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