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Radiology

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

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RecordFirmDate
HIPAX MEDICAL IMAGING SOFTWARE (K052411)Steinhart Medizinsysteme GmbH2005-09-21
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 (K051494)Cr Tech, Ltd.2005-09-21
GE LOGIQ 7 ULTRASOUND BT05 (K052441)General Electric Co.2005-09-21
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ (K052412)GE Healthcare2005-09-16
CORONIS 3MP-21 AND MFGD 3621 (K052429)Barcoview2005-09-15
CORONIS 2MP-21 AND MFGD 2621 (K052403)Barcoview2005-09-15
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K052355)U-Systems, Inc.2005-09-14
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C (K052344)Eizo Nanao Corporation2005-09-14
ADVANTAGE SIM MD (K052345)GE Healthcare2005-09-14
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K052325)Accuray Incorporated2005-09-14
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A (K052305)Siemens Medical Solutions USA, Inc.2005-09-08
SOMATOM DEFINITION (K052216)Siemens Medical Systems, Inc.2005-09-08
MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 (K052337)Eizo Nanao Corporation2005-09-08
SUPERDIMENSION/BRONCHUS 4.1 (K052260)Superdimension, Ltd.2005-09-08
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES (K052078)Philips Medical Systems Nederland B.V.2005-09-07
NSTRAND IMPLANTATION KIT (K052024)North American Scientific, Inc.2005-09-07
AIDA COMPACT II SYSTEM (K052159)KARL STORZ Endoscopy-America, Inc.2005-09-07
DAR-8000I (K052076)Shimadzu Medical Systems2005-09-02
DRYSTAR MODEL 5500 (K052251)Agfa Corporation2005-08-31
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (K052067)Multigon Industries, Inc.2005-08-29
GR17 DIGITAL DETECTOR (K052136)Anrad Corp.2005-08-25
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157)Ge Medical Systems, LLC2005-08-25
ACCESS BREAST COIL (K052045)Confirma, Inc.2005-08-24
CARDIOSTREAM SONOAIM (K051853)Cardiostream, LLC2005-08-22
DVT SCANNER (K051980)Imaging Sciences Intl., Inc.2005-08-19
TEM 3000 HEAD COIL (K052200)Mr Instruments, Inc.2005-08-19
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 (K051920)Volcano Corporation2005-08-19
CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 (K051305)Cs Medical, LLC2005-08-18
NIO 3MP-21 (K051901)Barcoview2005-08-17
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER (K052021)Siemens Medical Solutions USA, Inc.2005-08-17
G-SCAN CERVICAL SPINE COIL (K052077)Esaote, S.p.A.2005-08-16
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM (K051809)Medical Insight A/S2005-08-15
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT (K050320)Ascendia Medtech AB2005-08-15
ULTRAPACS (K051813)Ultrarad Corporation2005-08-15
ENSITE VERISMO SOFTWARE (K051840)St Jude Medical2005-08-15
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932)Elekta, Inc.2005-08-12
NIO 2MP-21 (K051902)Barcoview2005-08-11
GE OEC ALTITUDE (K052039)Ge Oec Medical Systems2005-08-11
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) (K052109)Sonosite,Inc.2005-08-11
MODEL SR-115 PORTABLE X-RAY SYSTEM (K052001)Source-Ray, Inc.2005-08-11
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM (K051941)Accuray, Inc.2005-08-09
SYNGO CIRCULATION (K052029)Siemens AG Medical Solutions2005-08-09
ORTHOSCAN, ORTHOSCAN HD (K051754)Orthoscan, Inc.2005-08-09
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K052113)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005-08-09
SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS (K052042)Sonoscape Company Limited2005-08-09
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS (K051967)GE Healthcare2005-08-09
VIEWSEND MEDICAL SYSTEM (K051586)Kenei Co., Ltd.2005-08-04
AVISO OPHTHALMIC ULTRASOUND SYSTEM (K051851)Quantel Medical2005-08-03
ACHIEVA 1.5T & INERA 1.5T FAMILY (K052013)Philips Medical Systems Nederland B.V.2005-08-02
VENTRI (K051855)Ge Medical Systems F.I. Haifa2005-08-02
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 (K051649)Camtronics Medical Systems2005-08-02
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM (K051639)As Software, Inc.2005-08-02
STARPACS DENTAL (K051715)Infinitt Co., Ltd.2005-08-02
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 (K051618)Midwest Rf, LLC2005-08-02
POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. (K051739)Multigon Industries, Inc.2005-07-28
THE EDGE DETECTOR, MODEL 1118 (K051921)Sun Nuclear Corp.2005-07-27
R2 BREAST IMAGING WORKSTATION (K051743)R2 Technology, Inc.2005-07-25
3TP WORKSPACE (K050862)3tp, LLC2005-07-25
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE (K051528)Mevis Technology GmbH & Co. KG2005-07-20
MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 (K051837)Esaote, S.p.A.2005-07-20
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION (K051523)Konica Minolta Medical & Graphic, Inc.2005-07-20
VITESSE 2.0 (K051497)Varian Medical Systems, Inc.2005-07-18
XELERIS 2 PROCESSING AND REVIEW WORKSTATION (K051673)GE Medical Systems2005-07-18
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER (K051833)Toshiba America Medical Systems, In.C2005-07-15
QD KNEE/FOOT COIL, MODEL MJQJ-147A (K051763)Toshiba America Medical Systems, In.C2005-07-14
19-INCH (48CM) COLOR LCD MONITOR CDL1904A (K051403)Totoku Electric Co., Ltd.2005-07-14
ECHOSYSTEM (K051745)Medstrat, Inc.2005-07-14
CERETOM, MODEL NL3000 (K051765)Neurologica Corporation2005-07-14
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K051549)Digirad Corp.2005-07-13
GE OEC EVERVIEW 7500 (K051490)Ge Oec Medical Systems, Inc.2005-07-07
FUJI SYNAPSE WORKSTATION SOFTWARE (K051553)Fujifilm Medical Systems U.S.A, Inc.2005-07-07
AXIOM SIRESKOP SD (K051602)Siemens Medical Systems, Inc.2005-07-07
SMITH & NEPHEW CDS SYSTEM (K051136)Smith & Nephew, Inc.2005-07-01
INSTANT-X, MODELS 1713 & 128 (K042791)Ann Arbor Digital Devices2005-07-01
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (K051423)Mick Radio-Nuclear Instruments, Inc.2005-07-01
DIRECT DIGITIZER REGIUS MODEL 370 (K051418)Konica Minolta Medical & Graphic, Inc.2005-07-01
NAVIGATOR (K042875)Nomos Corp.2005-07-01
BTI-SCAN, VERSION 4.0 (K051392)B.T.I. Biotechnology Institute, Sl.2005-06-29
CAC-127-8 CARDOAC ARRAY COIL (K051512)Invivo Corp.2005-06-28
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES (K050728)Usa Instruments, Inc.2005-06-28
IMAGEQUBE PACS (K051037)Intuitive Imaging Informatics, LLC2005-06-28
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION (K051521)Konica Minolta Medical & Graphic, Inc.2005-06-28
19-INCH (48 CM) COLOR LCD MONITOR CDL1902A (K051331)Totoku Electric Co., Ltd.2005-06-27
3.0T PROSTATE IMAGING SYSTEM (K051349)Medrad, Inc.2005-06-23
KODAK DIRECTVIEW DR SYSTEM DETECTOR (K051483)Eastman Kodak Company2005-06-21
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A (K051500)Toshiba America Medical Systems, In.C2005-06-17
GE VIVID 7 WITH OR WITHOUT SUFFIX (K051449)GE Medical Systems2005-06-16
MODIFICATION TO: SECTRA IDS5 WORKSTATION (K051315)Sectra Imtec AB2005-06-15
C.CAM-AC (K051460)Danish Diagnostic Development A/S2005-06-15
WEBPAX, MODEL 200 (K051325)Heart Imaging Technologies, LLC2005-06-15
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM (K051402)Gvi Technology Partners2005-06-13
PRECEDENCE SPECT/CT IMAGING SYSTEM (K051351)Adac Laboratories2005-06-08
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER (K051334)Teratech Corp.2005-06-03
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM (K051304)Science Surgical Corporation2005-06-03
KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 (K051127)Kika Medical, Inc.2005-06-03
MYLAB 70 ULTRASOUND IMAGING SYSTEM (K051308)Esaote, S.p.A.2005-06-01
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (K051258)Eastman Kodak Company2005-06-01
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE (K050925)Shimadzu Corp.2005-06-01
GAMMAPLAN (K051022)Elekta Instrument AB2005-06-01
ARCADIS AVANTIC (K051133)Siemens Medical Solutions USA, Inc.2005-06-01
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