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Radiology

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

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RecordFirmDate
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K050034)Siemens Medical Solutions USA, Inc.2005-01-13
MIRAGE, RELEASE 5.5 (K043441)Segami Corporation2005-01-13
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 (K043524)B-K Medical A/S2005-01-13
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING (K042602)Ge Medical Systems, LLC2005-01-13
ODYSSEY (K042861)Permedics, Inc.2005-01-12
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K043559)Sonosite,Inc.2005-01-12
GE SIGNA EXCITE MR SURGICAL OPTION (K043262)GE Healthcare2005-01-12
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K043563)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005-01-11
VOXAR 3D PRODUCT FAMILY (K043194)Voxar Limited2005-01-11
HD11 DIAGNOSTIC ULTRASOUND SYSTEM (K043535)Philips Ultrasound, Inc.2005-01-06
CADSTREAM VERSION 4.0 (K043216)Confirma, Inc.2005-01-06
IMPLANT SCIENCES CORP, MODEL HDR-4140 (K042864)Implant Sciences Corp.2005-01-06
MAMMOREPORT SOFTCOPY WORKSTATION (K042868)Siemens Medical Solutions USA, Inc.2005-01-06
IMT.LAB (K043360)Pie Medical2005-01-05
HORIZON MEDICAL IMAGING (K043146)Mckesson Medical Imaging Company2005-01-04
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) (K041125)Masep Med Science & Tech. Development (Shenzhen) C2004-12-30
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042221)Barco NV Barcoview2004-12-30
SURGPLAN AND PANPLAN (K041078)Imaging Sciences Intl., Inc.2004-12-23
SOMATOM RESPIRATORY GATING (K043086)Siemens Medical Solutions USA, Inc.2004-12-23
INFINIA LIGHTSPEED (K043381)Ge Medical Systems F.I. Haifa2004-12-23
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS (K042620)Tetrad Corp.2004-12-23
GE OEC FLUOROSTAR (K043076)Ge Oec Medical Systems, Inc.2004-12-22
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM (K043452)Sonosite,Inc.2004-12-21
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM (K043455)Medison Co., Ltd.2004-12-21
MODIFICATION TO: VIEWSTATION (K043412)Impac Medical Systems, Inc.2004-12-20
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U (K043293)Acrorad Co., Ltd.2004-12-17
MISTAR, MODEL V3.2 (K043350)Apollo Medical Imaging Technology Pty. , Ltd.2004-12-15
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM (K043333)Vital Images, Inc.2004-12-15
SOMATOM CARE CONTRAST CT (K043087)Siemens Medical Solutions USA, Inc.2004-12-15
SCENIUM (K042863)Siemens Molecular Imaging, Ltd.2004-12-15
DIRECT DIGITIZER, REGIUS MODEL 190 (K042386)Konica Minolta Medical & Graphic, Inc.2004-12-15
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES (K043278)Teratech Corp.2004-12-13
METRX WORKSTATION (K043134)Medical Metrx Solutions, Inc.2004-12-13
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM (K043062)Source-Ray, Inc.2004-12-13
PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 (K043287)Micromedical Devices, Inc.2004-12-10
BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER (K043117)Best Medical International, Inc.2004-12-09
MAGNETOM C! MR SYSTEM (K043030)Siemens Medical Solutions2004-12-09
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER (K043275)Olympus Medical Systems Corporation2004-12-09
SHIMADZU COLLIMATOR R-20J (K042840)Shimadzu Corp.2004-12-03
ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM (K043196)Aloka Co., Ltd.2004-11-30
X-LEONARDO (K042995)Siemens Medical Solutions USA, Inc.2004-11-24
AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS (K042353)National Display Systems2004-11-24
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM (K043112)General Electric Co.2004-11-24
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 (K042133)Konica Minolta Medical & Graphic, Inc.2004-11-24
NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042662)Barco NV Barcoview2004-11-22
MGP 15 DICOM THEATER (K042942)Barco NV Barcoview2004-11-22
PET-DOSE (K042746)Comecer S.R.L.2004-11-22
SECOND LOOK VIEWER (K042697)Icad, Inc.2004-11-19
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 (K043025)Analogic Corp.2004-11-19
NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042660)Barco NV Barcoview2004-11-19
IMALUX NIRIS IMAGING SYSTEM (K042894)Imalux Corporation2004-11-19
3VISEON (K043097)3Mensio Medical Imaging BV2004-11-19
PLANMED SOPHIE NUANCE CLASSIC (K042671)Planmed OY2004-11-19
NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042661)Barco NV Barcoview2004-11-19
BEST MODEL # 81-01 SERIES IR-192 SOURCES (K042786)Best Medical International, Inc.2004-11-18
URS LP DIGITAL, MILLENNIUM, RADPRO (K042876)Sedecal., Sa.2004-11-18
ADVANCED LUNG ANALYSIS II (K042694)GE Medical Systems2004-11-18
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR (K043002)Sedecal., Sa.2004-11-18
IOP8 INTRA OPERATIVE PROBE (K032315)Huntleigh Healthcare, Inc.2004-11-18
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A (K043111)Toshiba America Medical Systems, In.C2004-11-18
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A (K043078)Toshiba America Medical Systems, In.C2004-11-17
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM (K043016)Siemens Medical Solutions USA, Inc.2004-11-16
RESTITU (K041937)Resonant Medical, Inc.2004-11-16
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (K042733)Standard Imaging, Inc.2004-11-15
SENSATOUCH (K042250)Aluna Management Co., Ltd.2004-11-12
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA (K042718)Siemens Medi Cal Solutions, Inc.2004-11-12
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM (K042188)Volcano Therapeutics, Inc.2004-11-10
ACCUPACH V (K042752)Accutome Ultrasound, Inc.2004-11-10
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 (K041818)Boston Scientific Corp2004-11-10
TRAUMACAD 1.2 (K042816)Orthocrat, Ltd.2004-11-10
GEMINI GXL (K042935)Philips Medical Systems (Cleveland), Inc.2004-11-09
SUPERDIMENSION/BRONCHUS (K042438)Superdimension, Ltd.2004-11-08
IMAGE MEDICAL ACQUISITION STATION (IMAS) (K042700)Erad Imagemedical Corp.2004-11-08
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA (K042617)Siemens Medical Solutions USA, Inc.2004-11-05
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT (K042619)Sonotech, Inc.2004-11-05
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL (K042844)Ge Medical Systems, Inc.2004-11-03
BEST BREAST BRACHYTHERAPY APPLICATOR (K042586)Best Medical International, Inc.2004-11-03
HI-ART SYSTEM (K042739)Tomotherapy Incorporated2004-11-03
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM (K042948)Wandong Medical2004-11-03
JETSTREAM WORKSPACE (K042880)Adac Laboratories2004-11-03
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS (K042866)Ge Healthcare Technologies2004-11-02
PHILIPS ORTHOPAEDIC APPLICATIONS (K042867)Philips Medical Systems North America, Inc.2004-11-02
ON-BOARD IMAGER DEVICE (K042720)Varian Medical Systems2004-10-29
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS (K042480)Hologic, Inc.2004-10-29
C-PET PLUS IMAGING SYSTEM (K042839)Philips Medical Systems (Cleveland), Inc.2004-10-29
MAMMOTEST (K042095)Fischer Imaging Corp.2004-10-29
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) (K042793)Siemens Medi Cal Solutions, Inc.2004-10-29
AUTOSPECS (K042903)Adac Laboratories2004-10-29
ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) (K042831)Reichert, Inc.2004-10-28
SIENET COSMOS (VERSION V15A) (K042832)Siemens AG Medical Solutions2004-10-28
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS (K042833)Siemens Medical Solutions USA, Inc.2004-10-27
DIGITAL DETECTOR, MODEL GR17 (K042821)Anrad Corp.2004-10-22
UNFORS PATIENT SKIN DOSIMETER (PSD) (K042698)Unfors, Inc.2004-10-22
IMPLANTMASTER (K042212)I-Dent2004-10-21
RADIOTHERAPY SOLUTION BASED ON CR (K042779)Agfa Corp.2004-10-21
RSA-CMS (K042383)Medis Medical Imaging Systems BV2004-10-20
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM (K042770)Siemens Medical Solutions USA, Inc.2004-10-20
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER (K042484)Nai Technology Products2004-10-20
SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 (K042369)Sonoscape Company Limited2004-10-20
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT (K042445)Bard Access Systems, Inc.2004-10-19
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