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Radiology

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

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RecordFirmDate
SOMATOM SENSATION 64 AND SENSATION CARDIAC (K040665)Siemens Medical Solutions USA, Inc.2004-04-02
MODIFICATION TO ACCULEAF (K040553)Direx Systems Corp.2004-04-01
ULTRASOUND IMAGING SYSTEM, MODEL 7300 (K040596)Esaote, S.p.A.2004-03-31
QONTRAST (K040399)Amid2004-03-29
NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM (K040040)Barco NV Barcoview2004-03-29
NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM (K040041)Barco NV Barcoview2004-03-29
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY (K040719)Aloka Co., Ltd.2004-03-26
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 (K040050)Ge Medical Systems Navigation and Visualization IN2004-03-24
CARDIOMD-AC (K040616)Danish Diagnostic Development A/S2004-03-24
SOMATOM PROJECT P30L (K040577)Siemens Medical Systems, Inc.2004-03-22
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER (K040541)Varian Medical Systems, Inc.2004-03-22
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL (K040640)Igc-Medical Advances, Inc.2004-03-22
RTIST (K033955)Mirada Solutions , Ltd.2004-03-17
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM (K040039)Barco N.V.2004-03-17
CAAS II RVA (K033920)Pie Medical Imaging BV2004-03-17
WBR-FHR, WBR-FWB (K040370)Ultraspect , Ltd.2004-03-11
MEDIPACS (K040486)Neobit Co., Ltd.2004-03-11
MODIFICATION TO HRW-127 WRIST ARRAY COIL (K040349)Mri Devices Corp.2004-03-09
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE (K034059)Sectra AB2004-03-09
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS (K040502)Siemens Medical Solutions USA, Inc.2004-03-09
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL (K040348)Mri Devices Corp.2004-03-09
SIREMOBIL ISO-C 3D (K040347)Siemens Medical Systems, Inc.2004-03-09
QSC-127-INT SHOULDER ARRAY COIL SET (K040288)Mri Devices Corp.2004-03-05
CT-MASS (K033774)Medis Medical Imaging Systems BV2004-03-02
LIGHTSPEED 7.0 CT SCANNER SYSTEM (K040372)Ge Medical Systems, LLC2004-03-01
IMALUX OCT IMAGING SYSTEM (K033783)Imalux Coporation2004-03-01
ON-BOARD IMAGER DEVICE (K040192)Varian Medical Systems, Inc.2004-02-27
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM (K040409)Larsen & Toubro Limited2004-02-27
3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316 (K032555)Totoku Electric Co., Ltd.2004-02-26
AUTOQUANT PLUS (K040326)Adac Laboratories2004-02-25
VITREA2 VERSION 3.5 (K040305)Vital Images, Inc.2004-02-24
COLOR LCD DISPLAY, MODEL RADIFORCE R22 (K033466)Eizo Nanao Corporation2004-02-20
BRAIN PERFUSION OPTION (K033677)Philips Medical Systems (Cleveland), Inc.2004-02-20
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE (K032443)Shimadzu Corp.2004-02-20
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY (K033821)Eastman Kodak Company2004-02-20
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 (K034054)Med-Tec,Inc.2004-02-20
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 (K040251)Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc2004-02-20
INTEGRIS 3D-RA, RELEASE 4.2 (K040254)Philips Medical Systems North America Co.2004-02-19
QLAB QUANTIFICATION SOFTWARE (K040227)Philips Ultrasound2004-02-17
SIREMOBILE C06 (K040066)Siemens Medical Solutions USA, Inc.2004-02-12
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY (K032067)Proxima Therapeutics, Inc.2004-02-10
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE (K040142)Adac Laboratories2004-02-06
SIMULIX EVOLUTION (K033470)Nucletron Corporation2004-02-04
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 (K033828)Mick Radio-Nuclear Instruments, Inc.2004-02-02
ORTHOPACS (K033825)Etrauma.Com Corp.2004-02-02
MOBILE COMPACT DIGITAL CARDIAC CAMERA (K040057)Is2 Research, Inc.2004-02-02
PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF (K032628)United Radiology Systems, Inc.2004-02-02
SYNERGY SPINE ARRAY COIL (K033662)Philips Medical Systems, Inc.2004-02-02
MINXRAY, MODEL HF120/60H POWERPLUS (K040046)Minxray, Inc.2004-02-02
CHASE CARDIAC ANALYSIS SYSTEM (K032531)Chase Medical, Inc.2004-02-02
EMORY CARDIAC TOOLBOX VERSION 2.6 (K040141)Syntermed, Inc.2004-01-30
CP SLEEVE AND RIVER SLEEVE (K034062)Cp Medical2004-01-30
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS (K040060)Siemens Medical Solutions USA, Inc.2004-01-28
CA-1500 (K040028)R2 Technology, Inc.2004-01-22
INTUITION IMAGE (K032511)Brainlab AG2004-01-21
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) (K033956)Is2 Research, Inc.2004-01-20
MRJ (K033507)Paramed S.R.L.2004-01-20
SPIRIT 5000 CARDIAC COIL (K033490)Usa Instruments, Inc.2004-01-09
DIAMOND SETUP 2000 (K032886)K&S Assoc., Inc.2004-01-09
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L (K033377)Fujifilm Medical System U.S.A., Inc.2004-01-09
ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357)Philips Medical Systems (Cleveland), Inc.2004-01-09
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (K034003)Philips Ultrasound, Inc.2004-01-08
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339)Varian Medical Systems, Inc.2003-12-30
MEDICLUNG, RELEASE 1 (K033412)Medicsight2003-12-30
BEBIG ISOSEED I-125 (K033781)Bebig Isotopen-Und Medizintechnik GmbH2003-12-30
MYOLIGHT (K033874)Ge Medical Systems F.I. Haifa2003-12-30
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS (K033371)Varian Medical Systems2003-12-24
PORTASCAN BLADDER SCANNER, MODEL PA00146 (K033906)Mediwatch Plc2003-12-24
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 (K033001)Transphoton Corporation2003-12-24
ERGO SRS (K031281)3D Line USA, Inc.2003-12-23
SYNGO PERFUSION-CT (K033832)Siemens AG Medical Solutions2003-12-23
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 (K033712)Sectra-Imtec AB2003-12-23
TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343)Varian Medical Systems, Inc.2003-12-23
ALLEGRO IMAGING SYSTEM (K033782)Philips Medical Systems (Cleveland), Inc.2003-12-19
EXACTRAC GATING (K033287)Brainlab AG2003-12-19
SIENET COSMOS (K033831)Siemens AG Medical Solutions2003-12-19
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS (K033867)General Electric Co.2003-12-19
MEDICAL IMAGE DIGITIZER, MODEL 2908 (K033637)Array Corp.2003-12-17
MODIFICATION TO: NUCAMMA RX (K032779)Is2 Research, Inc.2003-12-17
PELVIC ARRAY COIL (K033753)Usa Instruments, Inc.2003-12-17
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL (K033235)Usa Instruments, Inc.2003-12-17
PACS SOFTWARE SOLUTION 2003 (K033624)Canon USA, Inc.2003-12-15
ACCUSOFT (K032171)Direx Systems Corp.2003-12-15
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L (K033604)Pie Medical2003-12-15
VANTAGE PRO ATTENUATION CORRECTION DEVICE (K033735)Adac Laboratories2003-12-12
CLARITY PET (K032866)Shared P.E.T. Imaging, LLC2003-12-12
ALLURA XPER FD20 (K033737)Philips Medical Systems North America, Inc.2003-12-09
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 (K033184)Shimadzu Corp.2003-12-09
AUTOGEL PAD (K031018)Rich-Mar Corp.2003-12-08
SENO ADVANTAGE (K033400)Ge Medical Systems W-4002003-12-04
ADVANTAGE PADDLE (K033202)Livingston Products, Inc.2003-12-03
XIO RADIATION TREATMENT PLANNING SYSTEM (K032762)Computerized Medical Systems, Inc.2003-12-02
CONSULTIVA CASE INPUT STATION, MODEL CIS-1 (K031132)Eastman Kodak Company2003-11-26
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER (K031524)Varian Medical Systems, Inc.2003-11-26
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER (K033561)Fujifilm Medical System U.S.A., Inc.2003-11-26
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 (K033292)Igc-Medical Advances, Inc.2003-11-26
MDIFICATION TO MEDIPRIME (K033013)Algotec Systems, Ltd.2003-11-25
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS (K033567)Mri Devices Corp.2003-11-25
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K033504)General Electric Co.2003-11-25
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ (K033431)Cti Pet Systems, Inc.2003-11-20
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