Atlas FDA

Radiology

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

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RecordFirmDate
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING (K103274)Sentinelle Medical, Inc.2011-08-18
CS 9300, CS 9300C (K103659)Trophy2011-08-18
SYNGO.CT VASCULAR ANALYSIS (K112020)Siemens Medi Cal Solutions, Inc.2011-08-18
ISROBOT MONA LISA (K111347)Biobot Surgical Pte., Ltd.2011-08-12
BRIVO XR385 (K103448)Ge Medical Systems, LLC2011-08-12
NIO COLOR 2MP (K111991)Barco N.V.2011-08-11
RADIOLOGICAL IMAGE PROCESSING SYSTEM (K102078)VATECH Co., Ltd.2011-08-10
RALCO (K110856)Ralco S.R.L.2011-08-10
C7 XR IMAGING SYSTEM (K111201)Lightlab Imaging, Inc.2011-08-10
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) (K112180)Infimed, Inc.2011-08-10
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY (K101517)Sedecal., Sa.2011-08-05
IBIS EXPLORER AND MARKUP SOFTWARE (K111319)Medqia2011-08-05
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V (K112054)Toshiba Medical Systems Corporation, Japan2011-08-05
GLIASITE RTS (K111931)Isoray Medical, Inc.2011-08-05
IMPAX NEXT GENERATION (K111945)Agfa Healthcare N.V.2011-08-05
VANTAGE TITAN 3T (K102489)Toshiba Medical Systems Corporation, Japan2011-08-02
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM (K110801)Direct Digital Imaging Technology (Beijing), Inc.2011-08-02
HEARTNAVIGATOR RELEASE 1 (K111245)Philips Medical Systems Nederland B.V.2011-07-29
INTELLISPACE PACS 4.X (K111804)Philips Healthcare Informatics, Inc.2011-07-28
VITREAVIEW SOFTWARE 6.1 (K111892)Vital Images, Inc.2011-07-28
MRI-Q SYSTEM (K111222)Resonance Health Analysis Services Pty, Ltd.2011-07-28
XELIS 3D (K103130)Infinitt Co., Ltd.2011-07-28
LOGIQ S8 (K111582)GE Healthcare2011-07-26
PICA WHOLE-BODY MRI SYSTEM (K110942)Time Medical Limited2011-07-26
INTEGRATED INNOVA - S5I SYSTEM OPTION (K111209)GE Healthcare2011-07-26
LOGIQ E9 (K110943)GE Healthcare2011-07-22
MYLABSEVEN, MYLABALPHA (K111302)Esaote, S.p.A.2011-07-22
AXXENT RADIATION SHIELD - RIGID (K111299)Xoft, an Icad Company2011-07-20
COMMUNIFY PACS VIEWER (K110797)Flying Squirrel Storage, LLC2011-07-20
OPTIMA CT660 (K110227)Ge Medical Systems, LLC2011-07-20
MOBILEDIAGNOST WDR (K111725)Sedecal., Sa.2011-07-19
BEL-CAT (K101181)Takara Belmont Corp.2011-07-19
OPTIMA XR120 (K111304)Ge Medical Systems, LLC2011-07-19
G-SCAN (K111803)Esaote, S.p.A.2011-07-15
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K111706)Volcano Corporation2011-07-15
E-CUBE 9 (K111864)Alpinion Medical Systems Co., Ltd.2011-07-15
CARA (K110869)Diagnos, Inc.2011-07-14
SANTEVIEW (K111312)Sehyun Co., Ltd.2011-07-13
CARDIAC SCANNER AND PROCESSING SYSTEM (K110507)Spectrum Dynamics (Israel) , Ltd.2011-07-13
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K111435)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2011-07-08
SV DBS VRAIN ARRAY (K111259)Midwest Rf, LLC2011-07-05
SIMPLANT 2011 (K110300)Materialise Dental NV2011-07-01
ENDOSCOUT TRACKING SYSTEM (K111226)Robin Medical, Inc.2011-07-01
SCANORA 3D (K110839)Soredex Palodex Group OY2011-06-30
EZONO 3000 (K102813)Life-Tech, Inc.2011-06-30
ACUSON (K111674)Siemens Medical Solutions USA, Inc.2011-06-30
CLIO/CLIOSOFT (K110886)Sota Precision Optics, Inc.2011-06-30
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM (K111340)Medtec, Inc.2011-06-28
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER (K110752)Highland Instruments2011-06-28
MONACO RTP SYSTEM (K110730)Computerized Medical Systems, Inc.2011-06-24
IMPAX VOLUME VIEWING (K111638)Agfa Healthcare N.V.2011-06-24
CX50 DIAGNOSTIC ULTRASOUND SYSTEM (K111513)Philips Ultrasound, Inc.2011-06-24
DISPOSABLE THYROID COLLAR (K110900)Bloxr Corporation2011-06-24
QLAB 8.1 QUANTIFICATION SOFTWARE (K110414)Philips Ultrasound, Inc.2011-06-21
CT-GUIDE NEEDLE GUIDANCE SYSTEM (K110812)Activiews, Ltd.2011-06-21
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX (K103476)Ge Medical Systems, LLC2011-06-16
MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY (K111237)Nec Display Solutions , Ltd.2011-06-15
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) (K111344)Infimed, Inc.2011-06-10
BIOGRAPH MMR (K103429)Siemens Medical Solutions USA, Inc.2011-06-08
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) (K103724)Eizo GmbH2011-06-08
DISCOVERY NM 630 (K111445)GE Healthcare2011-06-03
LUMINOS AGILE (K111292)Siemens Medical Solutions USA, Inc.2011-06-03
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM (K102479)Alara, Inc.2011-06-02
AOS ORION IR-192 SOURCE CABLE (K102811)Alpha-Omega Services, Inc.2011-06-02
REGUIS SIGMA (K103703)Konica Minolta Medical & Graphic, Inc.2011-06-02
MYLABGOLD (K110688)Esaote2011-06-02
THE IC-PRO SYSTEM (K110256)Paieon, Inc.2011-05-27
ECHOINSIGHT (K110447)Ultrasound Medical Devices, Inc.2011-05-27
KONIX ULTRASOUND GEL (K101952)Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2011-05-27
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN (K111098)Imaging Dynamics Company , Ltd.2011-05-27
4CH FLEX SPEEDER (K111251)Toshiba Medical Systems Coporation, Japan2011-05-27
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM (K110785)Toshiba Medical Systems Coporation, Japan2011-05-27
AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE (K102534)Aze, Ltd.2011-05-24
EBW NM 2.0 (K111336)Philips Medical Systems (Cleveland), Inc.2011-05-24
SICAT IMPLANT V1.2 (K103723)Sicat GmbH & Co. KG2011-05-20
SYNGO NEURO PBV-IR (K111052)Siemens Medical Solutions USA, Inc.2011-05-20
OIS SYMPHONY IMAGE MANAGMENT SYSTEM (K110006)Ophthalmic Imaging Systems2011-05-18
COLONCAD API 3.1 (K083423)Medicsight Plc2011-05-17
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (K101779)Jpi Healthcare Co, Ltd.2011-05-16
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K110510)Sonoscape Company Limited2011-05-16
31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T (K102748)Rapid Biomedical GmbH2011-05-13
COMPUTED RADDIOGRAPHY SCANNER (K102619)3Disc Americas2011-05-13
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM (K111227)Aloka Co., Ltd.2011-05-13
SYNGO.VIA WEB VIEWER (K111079)Siemens AG Medical Solutions2011-05-13
SIMPLEABI (K110628)Newman Medical2011-05-12
ACHILLES (K103633)Ge Medical Systems China Co., Ltd.2011-05-11
DOLPHIN IMAGING (K110430)Patterson Dental Supply, Inc.2011-05-11
EUNITY (K111164)Client Outlook, Inc.2011-05-06
GE LUNAR VISCERAL FAT SOFTWARE (K103730)Ge Medical Systems Ultrasound and Primary Care Dia2011-05-06
RADIOVISION (K111102)Haas Software2011-05-05
CENTRICITY PACS (K110875)GE Healthcare2011-05-05
DILON 6800 ACELLA (ACELLA) (K110384)Dilon Technologies, Inc.2011-05-03
READY VIEW (K110573)Ge Healthcare (Ge Medical Systems Scs)2011-05-03
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (K093640)Electron Jsco.2011-04-29
BIOMARC FIDUCIAL MARKER (K110772)Carbon Medical Technologies, Inc.2011-04-28
SECTRA MICRODOSE MAMMOGRAPHY (K110025)Sectra Imtec AB2011-04-28
UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (K103599)Meridian Medical Systems, LLC2011-04-27
CUBESCAN / BIOCON-700 (K111021)Mcube Technology Co., Ltd.2011-04-27
PRESTODR 4143 (K110849)Cmt Medical Technologies, Ltd.2011-04-26
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION (K110834)GE Healthcare2011-04-26
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