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Radiology

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

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RecordFirmDate
SYNAPSE 3D TENSOR ANALYSIS (K141514)Fujifilm Meidcal Systems U.S.A.,Inc.2014-09-03
CIVA SHEET PD-103 (K140490)Civatech Oncology, Inc.2014-08-29
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (K140342)Mindways Software, Inc.2014-08-29
DICOMPACS DX-R WITH FLAT PANEL (K141440)Oehm Und Rehbein GmbH2014-08-29
CLIMB MAMMOGRAPHY VIEWER SOFTWARE (K141364)Climb Medical Systems, Inc.2014-08-29
OPAL CHIRO, 20/20 P-DR (K141435)2020 Imaging2014-08-27
DOSELAB PRO (K141230)Mobius Medical Systems, LP2014-08-27
VixWin Platinum (K141451)Imaging Sciences International (Dba Gendex, LLC)2014-08-26
X-PORTE ULTRASOUND SYSTEM (K142017)FUJIFILM Sonosite, Inc.2014-08-22
CVI42 (K141480)Circle Cardiovascular Imaging, Inc.2014-08-22
BREAST SPEEDER CX, GRID HOLDER CX (K142002)Quality Electrodynamics, LLC2014-08-22
SYMBIA 6.0 (K142006)Siemens Medical Solutions USA, Inc.2014-08-21
LEICA FL800 (K141136)Leica Biosystems Richmond2014-08-19
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979)Philips Medical Systems Netherland BV2014-08-19
NOMAD MD 75K V HANDHELD X-RAY SYSTEM (K140723)Aribex, Inc.2014-08-19
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT (K140232)Siemens Medical Solutions USA, Inc.2014-08-14
SAGITTILT (K141787)Orfit Industries NV2014-08-07
TITAN 11 (K133695)Gemss Medical Systems Co., Ltd.2014-08-07
TON-95LH, PAX-I3D ORTHO (K132983)VATECH Co., Ltd.2014-08-07
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM (K141846)Siemens Medical Solutions USA, Inc.2014-08-07
BREAST VOLUME NAVIGATOR (K141870)Metritrack, LLC2014-08-07
ECLIPSE TREATMENT PLANNING SYSTEM (K141283)Varian Medical Systems, Inc.2014-08-07
LCD MONITOR (K140956)Nordicneurolab2014-08-07
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS (K141336)Varian Medical Systems, Inc.2014-08-06
NORAS OR HEAD HOLDER FLEXIBILITY (K133506)Noras Mri Products GmbH2014-08-06
ORTOMED (K131348)Infomed Servicios Informaticos S.L.2014-08-05
LOGIQ V5/LOGIQ V3 (K141768)GE Healthcare2014-08-04
MEDICAL LCD MONITOR (K141891)Kostec Co., Ltd.2014-08-04
JUSHA-C33C LCD MONITOR (K141684)Nanjing Jusha Display Technology Co., Ltd.2014-08-01
JUSHA-M33C LCD MONITOR (K141690)Nanjing Jusha Display Technology Co., Ltd.2014-08-01
JUSHA-C61 LCD MONITOR (K141679)Nanjing Jusha Display Technology Co., Ltd.2014-08-01
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR (K140551)Perkinelmer, Inc.2014-08-01
REMOTEYE VIEWER (K141061)Neologica S.R.L.2014-08-01
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) (K141302)Vital Images, Inc.2014-08-01
ENDOSIZE (K141475)Therenva Sas2014-07-31
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE (K141832)Neocoil, LLC2014-07-31
DIGIARC 100AU+ (K141672)Beijing East Whale Imaging Technology Co., Ltd.2014-07-31
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST (K141736)Philips Medical Systems Dmc GmbH2014-07-25
VOLUSON P6, VOLUSON P8 (K141675)GE Healthcare2014-07-25
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE (K133670)Neocoil, LLC2014-07-24
INFX-8000V, V5.30 (K133535)Toshibamedical Systems Corporation2014-07-23
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (K141652)Cedars-Sinai Medical Center2014-07-22
OARTRAC SYSTEM (K141154)Radiadyne2014-07-22
ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM (K141641)Zonare Medical Systems, Inc.2014-07-18
VOLUSON S6, VOLUSON S8 (K141639)GE Healthcare2014-07-18
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL (K140897)Siemens Medical Solutions USA, Inc.2014-07-18
DELWORKS DR SYSTEM (K140825)Del Medical, Inc.2014-07-17
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC (K141563)Rayence Co., Ltd.2014-07-16
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC (K141566)Rayence Co., Ltd.2014-07-16
ESIE APPS SUITE (K141554)Siemens Medical Solutions USA, Inc.2014-07-11
MYLABSIX ULTRASOUND SYSTEM (K141486)Esaote Europe B.V.2014-07-11
REUSABLE GUIDE (K141334)Koelis2014-07-11
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL (K140998)Quality Electrodynamics, LLC2014-07-11
VERADIUS (K133819)Philips Medical Systems Nederland B.V.2014-07-10
GANTRY BEAM LINE (K132919)Ion Beam Applications S.A.2014-07-10
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE (K131601)Qubyx Limited2014-07-07
SYNGO, CT DUAL ENERGY (K133648)Siemens Medical Solutions USA, Inc.2014-07-07
DCAS I (K140869)Gp&P Co., Ltd.2014-07-03
RS80A DIAGNOSTIC ULTRASOUND SYSTEM (K141620)Samsung Medison Co., Ltd.2014-07-02
MCKESSON RADIOLOGY (K140909)Mckesson Medical Imaging Company2014-07-02
AVREO INTERWORKS SYSTEM (K141556)Avreo, Inc.2014-07-02
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM (K141369)Philips Ultrasound, Inc.2014-07-02
ISOSEED (K140849)Eckert & Ziegler Bebig GmbH2014-07-02
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS (K133693)Canon, Inc.2014-07-01
CRC PC WITH SMART CHAMBER (K141413)Capintec, Inc.2014-06-27
SURGICAL NAVIGATION ADVANCED PLATFORM (K140819)Surgical Theater, LLC2014-06-27
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER (K140823)Varian Medical Systems, Inc.2014-06-27
PARI-PATH SURGICAL NAVIGATION SYSTEM (K133901)Paritic, Inc.2014-06-27
MDMC-12133 (K141428)Barco N.V.2014-06-27
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (K141454)Sony Electronics, Inc.2014-06-26
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (K141346)Sony Electronics, Inc.2014-06-26
LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM (K140803)Nucletron B.V.2014-06-26
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK (K133848)Heartvista, Inc.2014-06-25
MOBIUS3D (K140660)Mobius Medical Systems, LP2014-06-24
ADMIRE (K133646)Siemens Medical Systems, Inc.2014-06-20
RADSPA (K141329)Telerad Tech Private Limited2014-06-20
QUENTRY DOSE REVIEW (K141199)Brainlab AG2014-06-20
KONIX STERILE GEL (K130581)Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2014-06-18
ARIETTA 60/ARIETTAS60/ARIETTAV60 (K140443)Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014-06-16
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM (K132289)Gemss Medical Systems Co., Ltd.2014-06-16
PLANMECA ROMEXIS (K140713)Planmeca Oy2014-06-16
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION (K132524)Philips Medical Systems2014-06-13
KALARE (K133553)Toshiba America Medical Systems, In.C2014-06-13
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K140960)Hologic, Inc.2014-06-13
MR ELASTOGRAPHY (K140666)Philips Medical Systems Nederland B.V.2014-06-13
SENYINT PACS (K133098)Dalian Senyint Digital Medical System Co., Ltd.2014-06-13
ONCENTRA BRACHY (K132816)Nucletron B.V.2014-06-13
DURADIAGNOST (K141381)Philips Healthcare (Suzhou) Co., Ltd.2014-06-12
CELESTEION, PCA-9000A/2 (K140651)Toshibamedical Systems Corporation2014-06-11
INTRA-OPERATIVE ULTRASOUND TRANSDUCER (K140854)Hitachi Aloka Medical, Ltd.2014-06-11
MAMMI (K140996)General Equipment For Medical Imaging (Oncovision-2014-06-11
HEARTNAVIGATOR RELEASE 2.0 (K140138)Philips Medical Systems Nederland B.V.2014-06-10
DR 400 (K141192)Agfa Healthcare N.V.2014-06-06
LOGIQ S7 EXPERT, LOGIQ S7 PRO (K141261)GE Healthcare2014-06-05
MEDICAD CLASSIC (K140434)Hectec GmbH2014-06-05
0180 INTUITION, 0072 PRECISION (K140683)Arcoma AB2014-06-03
BRIGHTMATTER PLANNING SOFTWARE (K140337)Synaptive Medical, Inc.2014-06-02
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE (K140364)Chison Medical Imaging Co., Ltd.2014-06-02
ULTRASOUND SCANNER SYSTEM BK2300 (K140428)B-K Medical Aps2014-05-30
TERASON USMART3300 ULTRASOUND SYSTEM (K140773)Teratech Corp.2014-05-30
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