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Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ULTRASOUND SCANNER TYPE 2102 (K003986)B-K Medical A/S2001-04-03
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL (K003613)GE Medical Systems2001-04-03
PHILIPS BV LIBRA (K010762)Philips Medical Systems, Inc.2001-04-02
AT3C70 TRANSDUCER (K002856)Sonora Medical Systems2001-04-02
COUCH FOR TOTAL BODY RADIATION (K010063)Arplay Medical S.A.2001-04-02
GE CT-PET SYSTEM (K010641)Ge Medical Systems, Inc.2001-03-30
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721)Siemens Medical Corp.2001-03-30
ADC QS/IPD WORKSTATION (K010571)Agfa Corp.2001-03-28
MEDEVIEW SYSTEM (K002789)Medeview.Com2001-03-21
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK (K010058)Witt Biomedical Corporation2001-03-21
EXHALE DOPPLER SYSTEM (K010649)Broncus Technologies, Inc.2001-03-20
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM (K003899)Mri Devices Corp.2001-03-15
NEMIO (K010631)Toshiba America Medical Systems, In.C2001-03-15
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC (K010116)Planmed OY2001-03-15
3D-DOCTOR (K003746)Able Software Corp.2001-03-13
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM (K010062)Arplay Medical S.A.2001-03-13
BEAM BLOCK TRAYS (K004015)Arplay Medical S.A.2001-03-13
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI (K003947)GE Medical Systems2001-03-13
7230 ULTRASOUND IMAGING SYSTEM WITH TEI (K010405)Biosound Esaote, Inc.2001-03-13
PHILIPS BV PULSERA/ENDURA (K010435)Philips Medical Systems, Inc.2001-03-12
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM (K003837)Ge Oec Medical Systems2001-03-12
ATLAS MULTI-PURPOSE DSA SYSTEM (K010391)Cares Built, Inc.2001-03-12
ATHENA REMOTE CONTROLLED RF SYSTEM (K010392)Cares Built, Inc.2001-03-12
APOLLO MOBILE C ARM SYSTEM (K010393)Cares Built, Inc.2001-03-12
NICOLET VERSALAB (K010521)Nicolet Biomedical2001-03-09
NEWTOM QR-DVT 9000 (K003787)Aperio Services, LLC2001-03-08
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS (K003725)Pie Medical2001-03-01
LOGIQ 500 (K010329)General Electric Co.2001-03-01
ALI 3D TOOL MODULE FOR MEDICAL IMAGES (K003762)A.L.I. Technologies, Inc.2001-02-28
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL (K003946)GE Medical Systems2001-02-27
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE (K003672)Medge Platforms, Inc.2001-02-22
HRH-127 HEAD ARRAY COIL (K010140)Mri Devices Corp.2001-02-22
NUCAMMA BI90 (K003882)Is2 Research, Inc.2001-02-21
AURORA (K003651)Aurora Imaging Technology, Inc.2001-02-21
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (K010374)Sonosite,Inc.2001-02-21
ADVANTAGE WINDOWS CT/PET FUSION (K010336)Ge Medical Systems, Inc.2001-02-16
ONYX-RAD TELEMEDICINE PACS (K003607)Viztek, Inc.2001-02-15
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING (K003936)Tomtec Imaging Systems GmbH2001-02-14
BIOLUCENT MAMMOGRAPHY CUSHION (K003795)Biolucent, Inc.2001-02-14
KIMAX, MODEL 1024 (K010187)Medical Metrics, Inc.2001-02-14
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 (K003853)Philips Medical Systems (Cleveland), Inc.2001-02-13
ORBITER II CCI/SPECT ORBITER II CCI/SPECT (K010137)Siemens Medical Solutions USA, Inc.2001-02-13
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 (K003510)Visualization Technology, Inc.2001-02-12
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 (K003514)Shimadzu Medical Systems2001-02-12
MXR-2000 MOBILE X-RAY UNIT (K010304)Irom Imaging, Inc.2001-02-12
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 (K003515)Shimadzu Medical Systems2001-02-12
ULTRASOUND SCANNER TYPE 2101 (K003041)B-K Medical A/S2001-02-07
MODIFICATION TO ARTOSCAN M (K010057)Biosound Esaote, Inc.2001-02-02
SURGI-VISION GUIDEWIRE COIL (K003436)Surgi-Vision, Inc.2001-02-02
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL (K003655)Mri Devices Corp.2001-02-02
P3IMRT TM (K002237)Adac Laboratories2001-02-02
OPDIMA (K003945)Siemens Medical Solutions USA, Inc.2001-02-02
PORTALVISION (K003636)Varian Medical Systems, Inc.2001-02-02
X-RAY SYSTEM XR-MX (K004037)Karl Storz Endoscopy2001-02-02
SELECT SEED I-125 (K002429)Nucletron Corp.2001-02-02
ODYSSEY LX, MODEL 211320 (K003437)Philips Medical Systems (Cleveland), Inc.2001-02-02
CT PERFUSION 2 (K010042)General Electric Co.2001-01-30
VITREA 2 CT PERFUSION OPTION (K003639)Vital Images, Inc.2001-01-23
MAGNETOM RHAPSODY SYSTEM (K003628)Siemens Medical Solutions USA, Inc.2001-01-23
DIFFUSION TENSOR IMAGING OPTION (K003573)Ge Medical Systems, Inc.2001-01-23
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW (K003459)Philips Medical Systems North America, Inc.2001-01-22
VIEW READING STATION (K003688)Electromed Intl., Ltd.2001-01-22
NETRA WORKSTATION AND NETRAMD SOFTWARE (K003484)Scimage, Inc.2001-01-19
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 (K003481)Codonics, Inc.2001-01-19
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) (K003358)Smv America2001-01-19
VIVID 7 WITH SONOPAC, MODEL FB0008XX (K003931)Ge Medical Systems, Inc.2001-01-18
ACTIVE ARRAY CATHETER, MODEL CS-2000 (K001097)Image-Guided Neurologics, Inc.2001-01-18
U-SYSTEMS ULTRASOUND SYSTEM USI-2000 (K003479)U-Systems, Inc.2001-01-18
MRI LINE MARKER (K003736)I.Z.I. Corp.2001-01-18
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS (K003453)Fonar Corp.2001-01-18
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (K003575)GE Medical Systems2001-01-17
PORTABLE BREAST COMPRESSION DEVICE (K003775)Pem Technologies2001-01-12
260 CORVUS (K003292)Pie Medical2001-01-05
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) (K003330)Aktina Medical Physics Corp.2001-01-04
BRAIN COIL, MODEL 9800GE-64 (K003097)Midwest Rf, LLC2000-12-28
SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 (K003386)Midwest Rf, LLC2000-12-28
PHORMAX EAGLE SCANNER SYSTEM (K001499)Phormax Corp.2000-12-27
GYROSCAN INTERA 3.0T (K003516)Philips Medical Systems North America, Inc.2000-12-27
XISCAN 6000 IMAGING SYSTEM (K003568)Xitec, Inc.2000-12-27
ALOKA SSD-4000 (K003739)Aloka Co., Ltd.2000-12-27
V SCORE WITH AUTO GATE MODEL TBD (K003230)Vital Images, Inc.2000-12-27
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 (K003270)Nucletron Corp.2000-12-22
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL (K003685)Medical Advances, Inc.2000-12-22
GE ADVANCE NXI PET SYSTEM (K003849)Ge Medical Systems, Inc.2000-12-22
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL (K003366)Igc-Medical Advances, Inc.2000-12-22
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION (K003264)Ge Medical Systems F.I. Haifa2000-12-21
INTERACTIVE REAL TIME SCANNING PACKAGE (K003623)Siemens Medical Solutions USA, Inc.2000-12-21
MAGNETIC CONCERTO (K003192)Siemens Medical Solutions USA, Inc.2000-12-21
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING (K002942)Philips Medical Systems North America, Inc.2000-12-19
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM (K000081)Isotopes and Metals , Ltd.2000-12-19
NEURO II (K002964)Innovative Magnetic Resonance Imaging Systems, Inc.2000-12-19
X-POSURE SYSTEM VERSION 2 MAMMO (K003656)Pronosco A/S2000-12-15
ECAT PET SCANNER (K003241)Cti Pet Systems, Inc.2000-12-13
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL (K003144)Medical Advances, Inc.2000-12-13
EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR (K001550)Imatron, Inc.2000-12-11
UBM PLUS, MODEL P45 (K003141)Paradigm Medical Industries, Inc.2000-12-05
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION (K002782)Nuclear Diagnostics AB2000-12-05
MEDIPRIME (K002894)Algotec Systems, Ltd.2000-12-05
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (K002807)Acuson Corp.2000-12-01
SIREMOBIL ISO-C 3D (K003266)Siemens Medical Solutions USA, Inc.2000-12-01
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