Atlas FDA

Radiology

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

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RecordFirmDate
CURA COMPENSATOR (K131150)Cura Medical Technologies, LLC2013-07-30
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION (K131448)Koelis2013-07-26
DUOFLEX COIL SUITE (1.5T) (K130706)Mr Instruments, Inc.2013-07-25
IQQA-LIVER MULTIMODALITY SOFTWARE (K131498)Edda Technology, Inc.2013-07-25
XPERGUIDE (K131263)Philips Medical Systems Nederland B.V.2013-07-24
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K131690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-07-24
PERCUNAV SYSTEM (K132087)Philips Health Care2013-07-24
ESIE APPS SUITE (K132062)Siemens Medical Solutions USA, Inc.2013-07-23
ULTRAEXTEND USWS-900A V2.1 AND V3.1 (K131822)Toshiba America Medical Systems, In.C2013-07-23
FORUM GLAUCOMA WORKPLACE (K130648)Carl Zeiss Meditec, AG2013-07-23
ELIXBO PM545 (K130658)Xbo Medical Systems Co., Ltd.2013-07-19
ICT (K130224)Imris, Inc.2013-07-18
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) (K131137)Jvckenwood Corporation2013-07-18
NAOMI-CT (K123332)Lk Consulting Group2013-07-18
SOLID GEL PAD (K131905)Bluemtech2013-07-18
HERMES MEDICAL IMAGING SUITE V5.3 (K131233)Hermes Medical Solutions AB2013-07-16
RADVISION (K131428)Acoustic Medsystems, Inc.2013-07-16
PADSCAN HD SERIES BLADDER SCANNER (K131227)Carenoso Technology Co., Ltd.2013-07-12
INGENUITY DIGITAL PET/CT (K123599)Philips Healthcare (Cleveland)2013-07-12
MIPLATFORM MEDICAL IMAGING SUITE (K131424)Hinacom Software and Technology, Ltd.2013-07-12
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K131514)Ge Vingmed Ultrasound AS2013-07-12
2MP COLOR LCD MONITOR, RADIFORCE MX215 (K131090)Eizo Corporation2013-07-03
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, (K131106)Canon, Inc.2013-07-03
NEWTOM VGI AND NEWTOM 5G (K130442)Qr S.R.L.2013-07-03
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA (K130935)Rayence Co., Ltd.2013-07-02
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE (K130724)Straumann USA2013-06-28
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM (K130638)Philips Medical Systems Nederland B.V.2013-06-28
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR (K130549)Carl Zeiss Meditec, Inc.2013-06-26
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) (K131314)Swissray Medical AG2013-06-25
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION (K131489)Tractus Corporation2013-06-25
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K130833)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-06-21
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K131213)Sonoscape Company Limited2013-06-21
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A (K123106)Samsung Electronics Co., Ltd.2013-06-20
Z5 DIAGNOSTIC ULTRASOUND SYSTEM (K130695)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-06-19
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 (K131267)GE Healthcare2013-06-19
IU22 DIAGNOSTIC ULTRASOUND SYSTEM (K130499)Philips Ultrasound, Inc.2013-06-18
CHABNER XRT GARMENTS (K121284)Chabner Xrt, LLC2013-06-14
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K130542)Fujifilm Medical System U.S.A., Inc.2013-06-14
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K130992)Philips Medical Systems (Cleveland), Inc.2013-06-14
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K130801)Sonoscape Company Limited2013-06-14
EMORY CARDIAC TOOLBOX 3.2 (K130902)Syntermed, Inc.2013-06-14
I-MAX TOUCH 3D (K130443)Owandy2013-06-14
MAMMOMAT INSPIRATION PRIME (K123520)Siemens Medical Solutions USA, Inc.2013-06-11
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER (K131528)CIVCO Medical Instruments Co., Inc.2013-06-11
DR LONG LENGTH IMAGING SOFTWARE (K130567)Carestream Health, Inc.2013-06-11
IMR SOFTWARE APPLICATION (K123576)Philips Healthcare (Cleveland)2013-06-07
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD (K130636)Vidar Systems Corp.2013-06-07
XGEO GU60 (K123105)Samsung Electronics Co., Ltd.2013-06-07
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR (K130464)Carestream Health, Inc.2013-06-07
ISR'OBOT MONA LISA (K130944)Biobot Surgical Pte., Ltd.2013-06-07
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS (K130739)Siemens Medical Solutions USA, Inc.2013-06-06
AQUILION PRIME, V5.00 (K130645)Toshibamedical Systems Corporation2013-06-06
PHT-6500, PHT-60CFO (K130432)VATECH Co., Ltd.2013-05-31
SINGLE ENERGY (SE) FEMUR EXAMS (K130277)Hologic, Inc.2013-05-31
MR PERMEABILITY (K130278)Philips Medical Systems Nederland B.V.2013-05-29
ETIAM PACS COMPONENTS (K131392)Etiam S.A.S.U.2013-05-29
SCANORA 3DX (K130297)Palodex Group OY2013-05-29
NIO COLOR 3MP LED (K131295)Barco N.V.2013-05-29
CORONIS 3MP (K131246)Barco N.V.2013-05-24
TERASON USMART3200T ULTRASOUND SYSTEM (K131209)Teratech Corp.2013-05-24
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K131088)Sonoscape Company Limited2013-05-24
DISCOVERY MR750W 3.0T (K130115)Ge Medical Systems, LLC2013-05-23
ANYTHINK PACS WORKSTATION (K131299)Beijing Crealife Technology Co., Ltd.2013-05-22
ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842)Philips Medical Systems Nederland B.V.2013-05-21
NORDIC TUMOREX (K123306)Nordicneurolab2013-05-20
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL (K130457)Resonance Innovations, LLC2013-05-20
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT (K130885)Siemens Medical Solutions USA, Inc.2013-05-17
NEUROQ 3.6 (K130451)Syntermed, Inc.2013-05-17
THE VAULT SYSTEM (K124051)Somersault Orthopedics, Inc.2013-05-17
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (K130377)Medicatech USA2013-05-17
MAGNETOM SKYRA (K123510)Siemens Medical Solutions USA, Inc.2013-05-17
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME (K123603)Ge Healthcare Surgery GE Oec Medical Systems, Inc.2013-05-17
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 (K122644)Siemens Medical Solutions USA, Inc.2013-05-16
MOBILECT VIEWER (K123082)Nephosity, Inc.2013-05-16
4D VIEW (K131118)GE Healthcare2013-05-16
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 (K123985)Sensus Healthcare2013-05-14
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET (K123912)Spencer Fillmore2013-05-14
QLAB QUANTIFICATION SOFTWARE HEART MODEL (K130159)Philips Health Care2013-05-13
RAYSTATION (K130617)Raysearch Laboratories AB2013-05-10
HYPERION X9 (K123381)Cefla S.C.2013-05-10
X-RAY ATTENUATING CREAM (DEN120022)Bloxr Corporation2013-05-09
CONI (K130624)Globalmed2013-05-07
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER (K121243)MEDA Co., Ltd.2013-05-03
AQUILION LB TRITON V4.91 (K123500)Toshibamedical Systems Corporation2013-05-02
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET (K123941)Spencer Fillmore2013-04-30
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM (K122888)Cdr Systems, Inc.2013-04-30
DIAGNOSTICPRO EDGE (K130406)Vidar Systems Corp.2013-04-29
ICRCO 3600M (K122510)Icrco, Inc.2013-04-26
NVISION VLE IMAGING SYSTEM (K120800)Ninepoint Medical, Inc.2013-04-25
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) (K130318)Varian Medical Systems, X-Ray Products-Infimed2013-04-22
ECAT SCINTRON PET (K130269)Miegmbh2013-04-19
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR (K130772)Nec Display Solutions , Ltd.2013-04-18
PREXION3D ECLIPSE (K122199)The Yoshida Dental Mfg. Co., Ltd.2013-04-18
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T (K130883)Sedecal., Sa.2013-04-18
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR (K130770)Nec Display Solutions , Ltd.2013-04-18
BIOMARC GOLD FIDUCIAL MARKER (K130678)Carbon Medical Technologies, Inc.2013-04-12
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM (K130803)Samsung Medison Co., Ltd.2013-04-12
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 (K122537)Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2013-04-12
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION (K130884)Ge Medical Systems F.I. Haifa2013-04-12
ZMED VP4000 (K130929)Zmed, Inc.2013-04-12
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