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Radiology

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

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RecordFirmDate
ECLIPSE TREATMENT PLANNING SYSTEM (K102011)Varian Medical Systems, Inc.2010-09-03
GE LOGIQ P5 MODEL H44662LD (K101878)GE Healthcare2010-08-31
CS-SERIES-FP (K100102)Omega Medical Imaging, Inc.2010-08-31
MR RADIATION ONCOLOGY OPTIONS (K102155)Ge Medical Systems, LLC2010-08-31
MYLABONE ULTRASOUND SYSTEM (K101605)Esaote Europe B.V.2010-08-31
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS (K093689)Mr Medical Solutions, LLC2010-08-31
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA (K100141)Siemens Medical Solutions USA, Inc.2010-08-27
SHIMADZU COLLIMATOR R-20J (K101036)Shimadzu Corp.2010-08-26
METAFLEXCOIL (K101632)Neocoil, LLC2010-08-24
OSIRIX MD (K101342)Pixmeo Sarl2010-08-20
PROCEDURE REHEARSAL STUDIO (K093269)Simbionix , Ltd.2010-08-20
STN PROBE (K101816)Summit Doppler Systems, Inc.2010-08-19
NEONATE ARRAY COILS (K091047)Lmt Medical Systems GmbH2010-08-18
CURIEPACS (DICOM PACS SOFTWARE) (K102148)Moksha Digital Software Pvt Limited2010-08-17
DIGITAL RADIOGRAPHY (K102012)Canon Inc. -Medical Equipment Group2010-08-17
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (K101038)Acceletronics Digital Imaging, LLC2010-08-17
SYNGO TRUED SOFTWARE (K101749)Siemens Medical Solutions2010-08-16
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) (K090947)Totoku Electric Co., Ltd.2010-08-16
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND (K102113)Ge Medical Systems China Co., Ltd.2010-08-12
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K101757)Sonosite,Inc.2010-08-12
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR (K101751)Varian Medical Systems, Oncology Systems2010-08-10
SYNGO. PLAZA VA20A (K101666)Siemens AG Medical Solutions2010-08-10
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 (K091090)E-Woo Technology2010-08-09
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW (K101452)Capintec, Inc.2010-08-09
ALLURA XPER OR TABLE SERIES (K102005)Philips Medical Systems North America, Inc.2010-08-09
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K101508)Ion Beam Applications S.A.2010-08-06
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM (K102065)Medison Co., Ltd.2010-08-06
ICAD VERALOOK CTC CAD SOFTWARE (K091529)Icad, Inc.2010-08-04
CORRIDOR4DM V2010 MODEL: V2010 (K101279)Invia2010-08-04
SCANDIA-45 GAMMA CAMERA SYSTEM (K101391)Scandia Corporation2010-08-04
DUSIMETRY CHECK (K101503)Math Resolutions, LLC2010-08-04
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB (K101289)Air Techniques, Inc.2010-08-03
MROPEN (K101295)Paramed S.R.L.2010-07-28
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 (K101949)Shanghai Chenguang Medical Technologies Co, Ltd.2010-07-28
PROWESS PANTHER PROARC, MODEL VERSION 5.0 (K101076)Prowess, Inc.2010-07-27
SYNAPSE 3D BASIC TOOLS (K101662)Fujifilm Medical System U.S.A., Inc.2010-07-26
MED-SEG, MODEL BTMS 1000 (K092328)Bartron Medical Imaging, Inc.2010-07-26
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 (K101833)Infimed, Inc.2010-07-23
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 (K092830)VATECH Co., Ltd.2010-07-21
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 (K100766)Ion Beam Applications S.A.2010-07-21
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM (K101455)Medison Co., Ltd.2010-07-19
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM (K092713)Transamerican Medical Imaging2010-07-16
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM (K101829)Medison Co., Ltd.2010-07-16
PACSMATE MMD-5201M MONITOR (K101796)Iei Technology Corp.2010-07-15
FLAT PANEL DETECTOR, MODEL FDR D-EVO (K100762)Fujifilm Medical Systems U.S.A, Inc.2010-07-15
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 (K101858)Shanghai Chenguang Medical Technologies Co, Ltd.2010-07-14
VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890)Varian Medical Systems2010-07-13
SAVI PREPARATION DEVICE (K101411)Cianna Medical, Inc.2010-07-12
VARIAN TREATMENT (K093967)Varian Medical Systems, Inc.2010-07-12
UROSKOP OMNIA (K101491)Siemens Medical Solutions USA, Inc.2010-06-30
MOBIVISION (K100001)Almana Medical Imaging2010-06-25
ZURA TEE SYSTEM WITH CLARITEE PROBE (K100989)Imacor, Inc.2010-06-25
Z.ONE ULTRA ULTRASOUND SYSTEM (K101091)Zonare Medical Systems, Inc.2010-06-25
MYLABTWICE, MODEL 6200 (K100931)Esaote, S.p.A.2010-06-25
MIRADA XD (K101228)Mirada Medical, Ltd.2010-06-23
8 CHANNEL CARDIAC PHASED ARRAY COIL (K101492)Ge Healthcare Coils (Usa Instruments, Inc.)2010-06-23
CEDARA WEBACCESS, MODEL: 2.4 (K092915)Cedara Software Corp.2010-06-23
CORONIS FUSION 10MP, MODEL MDCG-10130 (K093197)Barco N.V.2010-06-23
PUMA MODEL VERSION 1.0 (K100801)Prowess, Inc.2010-06-18
BF-NAVI (K093810)Kgt, Inc.2010-06-18
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS (K093466)Hitachi Medical Systems America, Inc.2010-06-17
FIDUCIAL MARKERS (K101131)Cosman Medical, Inc.2010-06-17
O-ARM IMAGING SYSTEM (K092564)Medtronic Navigation, Inc. (Littleton)2010-06-17
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE (K093395)Olympus Medical Systems Corporation2010-06-17
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 (K101119)Siemens Medical Solutions USA, Inc.2010-06-16
10 X 10 VISION (K091928)Bioptics, Inc.2010-06-16
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY (K101008)Shantou Institute of Ultrasonic Instruments (Siui2010-06-08
MODIFICATION TO SCINTRON IV (K101013)Miegmbh2010-06-07
SYNGO.CT CORONARY ANALYSIS (K100637)Siemens AG Medical Solutions2010-05-26
SYNC-RX SYSTEM, MODEL AS00010 (K100849)Sync-Rx, Ltd.2010-05-21
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 (K100847)Biocompatibles, Inc.2010-05-21
ULTRA DCI MODEL 5000 (K100363)Ultrasound Medical Devices, Inc.2010-05-21
MRI PATIENT POSITIONING DEVICES (K093738)Medtec, Inc.2010-05-14
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA (K092164)Shenzhen Delicate Electronics Co., Ltd.2010-05-13
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 (K100691)Bionix Development Corp.2010-05-11
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 (K100619)Siemens Medical Solutions USA, Inc.2010-05-07
MEDCOM RT-VIEWER SYSTEM (K100056)Medcom GmbH2010-05-07
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K100830)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-05-05
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K101041)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-04-30
CAAS QVA 3D, CAAS QCA 3D (K100292)Pie Medical Imaging BV2010-04-30
C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES (K093857)Lightlab Imaging, Inc.2010-04-30
ILUMA VISION MODEL VERSION 2.2 (K094064)3M Imtec2010-04-30
ERGO IMAGING SYSTEM (K100838)Digirad Corp.2010-04-23
MINXRAY MODEL CMDR-2S (K100449)Minxray, Inc.2010-04-23
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART (K100096)Integra Radionics, Inc.2010-04-22
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 (K100113)Sentinelle Medical, Inc.2010-04-22
PRESTODR PORTABLE (K100400)Cmt Medical Technologies, Ltd.2010-04-22
COMPACT TOUCH (K094038)Quantel S.A.2010-04-22
SYNAPSE OBLIQUUS MIP/MPR/FUSION (K100881)Fujifilm Medical System U.S.A., Inc.2010-04-14
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 (K100264)Bionix Development Corp.2010-04-09
MASTER-VU A-SCAN, MV4500 (K100252)Sonomed, Inc.2010-04-09
XKNIFE 5 (K100417)Integra Radionics, Inc.2010-04-08
ORS VISUAL (K100335)Object Research Systems, Inc.2010-04-08
DIGITAL SPOT MAMMOGRAPHY SYSTEM (K100692)Hologic, Inc.2010-04-06
MODEL DGH 6000 SCANMATE A (K093371)Dgh Technology, Inc.2010-04-05
MR INSPIRE WITH EXTENDED KIT (K100164)Paramed S.R.L.2010-04-05
SIMONDR DRP (K093790)Simondr, Inc.2010-04-05
S-SCAN, MODEL 9800020010 (K100670)Esaote, S.p.A.2010-04-05
PROXISCAN MODEL 101 (K093706)Hybridyne Imaging Technologies, Inc.2010-04-02
STAIR SYSTEMS PACS & DICOM VIEWER (K100236)Stair Systems, Inc.2010-03-29
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