Atlas FDA

Radiology

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

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RecordFirmDate
VIVIX-S WITH VXVUE (K122866)Vieworks Co., Ltd.2013-01-11
1.5T GEM RT OPEN ARRAY (K123327)Ge Healthcare Coils (Usa Instruments, Inc.)2013-01-11
VIZION + DR (K123644)Viztek, LLC2013-01-11
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836)Lorad, A Hologic Co.2013-01-11
SPECBOARD JR. (K123414)Macbrud Corp., Medical Division2013-01-11
BEST LOCALIZATION NEEDLE WITH I-125 SEED (K122704)Best Medical Intl.2013-01-09
ALIGNRT PLUS (K123371)Vision RT Limited2013-01-08
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS (K122457)GE Healthcare2013-01-02
INTERVENTIONAL WORKSPOT (K121296)Philips Medical Systems Nederland B.V.2013-01-02
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA (K122919)Rayence Co., Ltd.2013-01-01
ONQ RTS (K123357)Oncology Systems, Inc.2012-12-28
RAPID STRAND RX (K122764)Medi-Physics, Inc.2012-12-28
SYNGO SINGLE SOURCE DUAL ENGERY (K122909)Siemens Medical Systems, Inc.2012-12-27
CLEARREAD +CONFIRM (K123526)Riverain Technologies2012-12-27
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T (K123091)Imris, Inc.2012-12-27
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS (K121653)Carl Zeiss Meditec, Inc.2012-12-27
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM (K123754)Philips Ultrasound, Inc.2012-12-21
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM (K123616)Sonoscape Company Limited2012-12-21
PREXION 3D (K120948)The Yoshida Dental Mfg. Co., Ltd.2012-12-21
E-CUBE 7 (K123611)Alpinion Medical Systems Co., Ltd.2012-12-21
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE (K122106)Veran Medical Technologies, Inc.2012-12-21
PANTHER OIS/R & V MODEL VERSION 2.0 (K122616)Prowess, Inc.2012-12-21
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 (K122897)Invivo Corporation2012-12-21
TRUEBEAM (K123291)Varian Medical Systems, Inc.2012-12-20
AEROPILOT (K123499)Konica Minolta Medical & Graphic, Inc.2012-12-20
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) (K123530)Hologic, Inc.2012-12-20
SCENIUM (K123528)Siemens Medical Solutions USA, Inc.2012-12-20
SYNGO, CT CARDIAC FUNCTION (K123585)Siemens Medical Solutions USA, Inc.2012-12-20
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM (K123564)GE Healthcare2012-12-18
HERMES MEDICAL IMAGING SUITE V5.2 (K121278)Hermes Medical Solutions AB2012-12-18
PERCUNAV (K121498)Philips Health Care2012-12-14
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (K122840)Mick Radio-Nuclear Instruments, Inc.2012-12-14
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US (K122613)Toshiba America Medical Systems, In.C2012-12-13
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM (K123503)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-12-13
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) (K123492)Philips Medical Systems2012-12-13
PRESTO 1000 SYSTEM (K123565)Physiosonics, Inc.2012-12-13
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K123230)Impac Medical Systems, Inc.2012-12-12
MAVRIC SL (K113394)Ge Medical Systems, LLC2012-12-11
CARDNAV (K120282)Paieon, Inc.2012-12-10
OP300 (K122018)Palodex Group OY2012-12-10
VITESSE 3.0 (K123152)Varian Medical Systems, Oncology Systems2012-12-07
DDRVERSA MOTION (K123005)Swissray Medical AG2012-12-07
MRJ 3300 (K122034)Paramed S.R.L.2012-12-06
CLARITY (K121663)Elekta , Ltd.2012-12-05
LESSRAY (K123226)Saferay Spine, LLC2012-12-05
CALYPSO SYSTEM (K123137)Varian Medical Systems2012-12-05
ACUSON (K123622)Siemens Medical Solutions USA, Inc.2012-12-05
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT (K120995)Erad, Inc.2012-12-03
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL (K122429)Object Research Systems (Ors), Inc.2012-11-28
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR (K122495)Perkinelmer, Inc.2012-11-28
.DECIMAL PHOTON BLOCK (K123015).Decimal, Inc.2012-11-21
PLANMED NUANCE DIGIGUIDE (K121963)Planmed OY2012-11-21
PHT-6500; PHT-60CFO; PAX-I3D (K122606)Mtechgroup2012-11-20
SYNGO.VIA (K123375)Siemens AG2012-11-20
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (K121499)Fujifilm Medical System U.S.A., Inc.2012-11-20
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION (K122454)Fujifilm Medical System U.S.A., Inc.2012-11-20
PEDIATRIC POSITIONER PAD SET (K122174)Ge Healthcare Coils (Usa Instruments, Inc.)2012-11-16
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER (K123174)GE Healthcare2012-11-16
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER (K122236)Varian Medical Systems, Inc.2012-11-16
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM (K121792)Neusoft Medical Systems Co., Ltd.2012-11-16
STEREOS WORKSTATION (K113344)Eos Imaging2012-11-16
OPTIMA MR 430S (K123068)Ge Medical Systems, LLC2012-11-13
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO (K121434)Siemens Medi Cal Solutions, Inc.2012-11-05
FLIGHTPLAN FOR LIVER (K121200)GE Healthcare2012-11-02
VITREAADVANCED (K121213)Vital Images, Inc.2012-11-02
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH (K122938)Carl Zeiss Meditec, AG2012-11-02
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM (K123185)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-11-02
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T (K122646)Invivo Corporation2012-11-02
ECHONAVIGATOR RELEASE 1 (K121781)Philips Medical Systems Nederland B.V.2012-10-26
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER (K120796)Superdimension, Inc.2012-10-26
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM (K123001)Siemens Medical Solutions USA, Inc.2012-10-26
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137)Accuray Incorporated2012-10-26
GE 8CH FOOT ANKLE COIL (K122694)Ge Hangwei Medical Systems Co., Ltd.2012-10-25
IMAGE-COM 5.0 (K122289)Tomtec Imaging Systems GmbH2012-10-24
IMAGEN3D (K122241)Cardiovascular Imaging Technologies2012-10-24
CARESTREAM VUE PACS (K122523)Carestream Health, Inc.2012-10-23
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR (K121657)Proton Systems2012-10-23
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC (K122173)Rayence Co., Ltd.2012-10-19
SDX SYSTEM (K121845)Dyn'R Sas2012-10-19
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 (K121564)Olympus Medical Systems Corp.2012-10-16
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 (K122574)Edan Instruments, Inc.2012-10-12
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (K121076)Toshiba America Medical Systems, In.C2012-10-09
RADREX-I, SW V4.00 MODEL DRAD-3000E (K122842)Toshiba America Medical Systems, In.C2012-10-09
TBS INSIGHT (K121716)Medimaps Group SA2012-10-05
DFP4343C7 (K122589)Mdi Consultants, Inc.2012-10-05
C1-6-D ULTRASOUND TRANSDUCER (K122921)GE Healthcare2012-10-05
MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR (K122843)Prodigy Technology Consultant Co., Ltd.2012-10-05
PORTA 100HF (K122697)Job Corporation2012-10-05
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS (K122450)Mitsubishi Heavy Industries, Ltd.2012-10-03
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER (K122009)Panasonic Healthcare Co., Ltd.2012-10-03
LOGIQ S7 EXPERT, LOGIQ S7 PRO (K122114)GE Healthcare2012-10-03
EXACTRAC VERO (K122451)Brainlab AG2012-09-28
ACUSON (K122825)Siemens Medical Solutions USA, Inc.2012-09-28
ATHEROEDGE (K122022)Atheropoint, LLC2012-09-26
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (K113483)Philips Healthcare (Cleveland)2012-09-26
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 (K122341)Hitachi Aloka Medical, Ltd.2012-09-26
FAXITRON SPECIEN RADIOGRAPHY SYSTEM (K122428)Faxitron Bioptics, LLC2012-09-25
TOSHIBA 3T 32CH HEAD SPEEDER COIL, (K122638)Quality Electrodynamics2012-09-25
PRISM ACQUIRE PRISM PROCESS PRISM VIEW (K122026)Prism Clinical Imaging, Inc.2012-09-21
ECHOSOFT(TM) (K111142)Echometrix, LLC2012-09-21
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