Atlas FDA

Radiology

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

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RecordFirmDate
KODAK CARESTREAM PACS (K053347)Eastman Kodak Company2006-01-04
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM (K053530)Medison Co., Ltd.2006-01-03
CAAS (K052988)Pie Medical Imaging BV2005-12-30
21.3INCH MONOCHROME LCD MONITOR (K052942)Nec-Mitsubishi Electric Visual Systems Corp.2005-12-27
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF (K052587)J. Morita USA, Inc.2005-12-27
WEB1000 (K053458)Agfa Corp.2005-12-22
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (K050843)Xoft, Inc.2005-12-22
UROVANTAGE (K053279)Pck Electronic Industry & Trade Co., Ltd.2005-12-22
BRAIN VIEWRX VIEWER, VERSION 1.0 (K052467)Kyron Clinical Imaging, Inc.2005-12-20
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 (K052120)Heeyoung Co., Ltd.2005-12-16
GE VOLUSON I (K053435)General Electric Co.2005-12-16
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM (K053154)Pie Medical2005-12-16
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE (K052632)Vital Images, Inc.2005-12-15
DS CASSETTE (K053173)Konica Minolta Medical & Graphic, Inc.2005-12-15
DDRFORMULA AND DDRFORMULA PLUS (K052943)Swissray Medical AG2005-12-15
DEXTROSCOPE & DEXTROBEAM (K053162)Volume Interactions Pte, Ltd.2005-12-09
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER (K053258)Hitachi Medical Corp.2005-12-09
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 (K053346)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005-12-09
CADIMAS VERSION 1.0 (K052023)Alan Penn & Associates., Inc.2005-12-08
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) (K053281)Emageon, Inc.2005-12-07
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 (K053325)Mediwatch, Ltd.2005-12-07
MEDIQ VERSION 1.0 (K052963)Clario Medical Imaging, Inc.2005-12-05
SYNGO DYNAMICS, VERSION 5.0 (K053133)Siemens Medical Solutions USA, Inc.2005-12-05
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV (K052348)Volcano Corporation2005-12-02
IMAGE STAR II (K052610)Lakeshore Technologies, Inc.2005-11-30
VIMPLANT (K053155)Cybermed, Inc.2005-11-23
VISION (WITH OFF-LINE REVIEW) (K052391)Varian Medical Systems2005-11-23
SONOLINE G60 S ULTRASOUND SYSTEM (K052894)Siemens Medical Solutions USA, Inc.2005-11-23
VISTADENT AT COMPLETE, MODEL 3.1 (K053010)Dentsply Intl., Inc.2005-11-22
ENCOMPASS SOFTWARE PACKAGE (K053043)Toshiba America Medical Systems, In.C2005-11-18
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K053009)GE Medical Systems2005-11-17
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE (K053042)Medrad, Inc.2005-11-17
IMAGECAST PACS (K052618)Idx Systems Corp.2005-11-17
CR-PRO (K052938)Eradlink, Inc.2005-11-17
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM (K053084)Kontron Medical Systems Sas2005-11-16
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 (K052537)American Medical Sales, Inc.2005-11-16
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K053069)Sonosite,Inc.2005-11-16
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS (K053017)Invivo Corporation2005-11-16
COLOR NIO 2MP, E-2320 C (K052958)Barcoview2005-11-16
SUPERDIMENSION/BRONCHUS PREMIUM (K052852)Superdimension, Ltd.2005-11-14
ACUSON CYPRESS ULTRASOUND SYSTEM (K052331)Siemens Medical Solutions USA, Inc.2005-11-10
SMIT SLEEVE (K052228)Nucletron Corporation2005-11-09
GE 1.5T SIGNA HDE MR SYSTEM (K052978)Ge Medical Systems, LLC2005-11-09
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY (K052916)Usa Instruments, Inc.2005-11-09
ILUMA ORTHOCAT/DENTALCAT (K053046)Imtec Corp.2005-11-08
ADVANTAGE WORKSTATION 4.3. (K052995)GE Healthcare2005-11-08
GE DEFINIUM AMX 700, MODEL AMX 700 (K052897)General Electric Medical Systems2005-11-08
CRC 15ULTRA (K052595)Capintec, Inc.2005-11-08
MODIFICATION TO: AURORA (K052698)Aurora Imaging Technology, Inc.2005-11-08
INFINITT G3 PACS (K052545)Infinitt Co., Ltd.2005-11-08
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC (K052987)Noras Rontgen-Und Medizintechnik GmbH2005-11-08
SYNGO NEURO DSA CT (K053024)Siemens AG2005-11-04
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM (K052541)Avant Medical Systems2005-11-03
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE (K052704)Invivo Corp.2005-11-03
REGIUS MODEL 170 DIRECT DIGITIZER (K051998)Konica Minolta Medical & Graphic, Inc.2005-11-03
ECLIPSE TREATMENT PLANNING SYSTEM (K050296)Varian Medical Systems2005-11-03
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 (K052095)Konica Minolta Medical & Graphic, Inc.2005-11-03
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS (K052827)Medrad, Inc.2005-11-01
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) (K052775)Siemens AG Medical Solutions2005-10-31
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM (K052911)Medison Co., Ltd.2005-10-31
MIM 3.5 (CIRCA) (K052379)Mimvista Corp.2005-10-31
STARSPEED SERIES CT SCANNER SYSTEMS (K052855)GE Healthcare2005-10-28
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 (K052473)Inter Medical Medizintechnik GmbH2005-10-28
FOURSIGHT VIEWTOOL IMAGE VIEWER (K052895)Siemens Medical Solutions USA, Inc.2005-10-27
MINXRAY, MODEL HF100H+ (K052721)Minxray, Inc.2005-10-27
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR (K052884)Toshiba America Medical Systems, In.C2005-10-26
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (K052361)Nucletron Corporation2005-10-24
LUNAR IDXA (K052581)Ge Medical Systems Ultrasound and Primary Care Dia2005-10-20
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (K052433)Bioptics, Inc.2005-10-18
DAR-8000F (K052500)Shimadzu Medical Systems2005-10-17
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 (K052571)Neurognostics, Inc.2005-10-17
HDR IORT SHIELDED APPLICATOR (K052351)Mick Radio-Nuclear Instruments, Inc.2005-10-17
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 (K052805)Esaote, S.p.A.2005-10-17
REFORMAT GATEWAY (K052284)Infinitt Co., Ltd.2005-10-17
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A (K052497)Invivo Corp.2005-10-12
AJEX 9015/135H PORTABLE X-RAY (K052341)Jpi America, Inc.2005-10-07
GEMINI RAPTOR (K052640)Philips Medical Systems (Cleveland), Inc.2005-10-07
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL (K052621)Usa Instruments, Inc.2005-10-07
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM (K052312)Wide Corporation2005-10-07
1.5T 12 CHANNEL BODY ARRAY (K052584)Usa Instruments, Inc.2005-10-07
ETIAM STAR PACS COMPONENTS (K052358)Etiam, S.A.2005-10-05
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A (K052164)Siemens Medical Solutions USA, Inc.2005-10-04
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K052430)Digirad Corp.2005-10-04
3T HD BREAST ARRAY (K052585)Usa Instruments, Inc.2005-10-04
COLOR CORONIS 2MP-21 AND MFCD 2321 (K052352)Barcoview2005-09-30
E-2320 PA S (K052529)Barcoview2005-09-30
IPLAN RT FIBERTRACKING (K052220)Brainlab AG2005-09-30
SITE-RITE 5 ULTRASOUND SYSTEM (K052517)C.R. Bard, Inc.2005-09-29
MFCD 1219, MFCD 1219 TS (K052478)Barcoview2005-09-28
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM (K052172)Hitachi Medical Systems America, Inc.2005-09-27
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K052434)GE Medical Systems2005-09-27
PORTAL GRAVITY SYSTEM (K052579)Portal, Inc.2005-09-27
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) (K052199)Totoku Electric Co., Ltd.2005-09-22
SIMTEC IM-MAXX 2 OPTION (K052315)Siemens Medical Solutions USA, Inc.2005-09-22
SYNGO IMAGING VERSION V20A (K052461)Siemens AG Medical Solutions2005-09-22
ACUSON SEQUOIA ULTRASOUND SYSTEM (K052410)Siemens Medical Solutions USA, Inc.2005-09-22
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE (K052460)Ramsoft, Inc.2005-09-21
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293)Ge Medical Systems, LLC2005-09-21
NIO 2MP-20 AND E-2620 S (K052276)Barcoview2005-09-21
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 (K052447)Analogic Corp.2005-09-21
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