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Radiology

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

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RecordFirmDate
KINETDX (K041029)Siemens Medi Cal Solutions, Inc.2004-07-08
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 (K041688)General Electric Co.2004-07-08
CADSTREAM VERSION 3.1 (K041020)Confirma, Inc.2004-07-07
GE VIVID 7 BT04 (K041552)General Electric Co.2004-07-02
SOURCELINK (K041576)C.R. Bard, Inc.2004-07-02
PRECISION RXI ANALOG X-RAY SYSTEM (K041605)General Medical Merate S.P.A2004-06-30
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W (K041557)Thomson & Nielsen Electronics, Ltd.2004-06-25
ONEDOSE PATIENT DOSIMETRY SYSTEM (K040687)Sicel Technologies, Inc.2004-06-25
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K041577)Adac Laboratories2004-06-25
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 (K041597)Eizo Nanao Corporation2004-06-24
ACCUSOFT (K040474)Direx Systems Corp.2004-06-23
GE DISCOVERY ST (K041543)GE Healthcare2004-06-22
COMPACS, VERSION 1.0 (K041581)Intelligent Images Srl2004-06-22
VOLUME VIEWER PLUS (K041521)General Electric Medical Systems2004-06-22
STARPACS ORTHOPEDICS SYSTEM (K041500)Infinitt Co., Ltd.2004-06-21
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR (K040704)Mick Radio-Nuclear Instruments, Inc.2004-06-18
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT (K041487)Usa Instruments, Inc.2004-06-17
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS (K041542)Neusoft Digital Medical Systems Co., Ltd.2004-06-17
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM (K041476)Ge Medical Systems, LLC2004-06-17
NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS (K040310)National Display Systems2004-06-17
NEUROQ - PET DP (K041022)Syntermed, Inc.2004-06-17
HEXAPOD RT COUCHTOP (K041448)Medical Intelligence Medizintechnik GmbH2004-06-16
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I (K040443)Dome Imaging Systems, Inc.2004-06-16
OLINDA/EXM (K033960)Vanderbilt University2004-06-15
GE DISCOVERY ST SYSTEM (K041220)GE Medical Systems2004-06-15
21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A) (K040697)Totoku Electric Co., Ltd.2004-06-10
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K041315)Accuray, Inc.2004-06-10
AXIOM ARTIS U (K040675)Siemens Medical Systems, Inc.2004-06-10
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K041455)Sonoscape Company Limited2004-06-10
ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 (K040926)Hudson Diagnostic Imaging, LLC2004-06-10
SSA-770A, APLIO VERSION 5.5 (K041499)Toshibamedical Systems Corporation2004-06-10
EG-3830UT (K041397)Pentax Precision Instrument Corp.2004-06-09
EG-3630UR (K041395)Pentax Precision Instrument Corp.2004-06-09
FG-36UX FIBER ULTRASOUND GASTROSCOPE (K041396)Pentax Precision Instrument Corp.2004-06-09
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR (K041380)R2 Technology, Inc.2004-06-08
MRA-CMS (K040746)Medis Medical Imaging Systems BV2004-06-08
IPACS ORTHO (K041366)Realtimeimage, Inc.2004-06-08
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM (K041319)Siemens Medical Solutions USA, Inc.2004-06-07
ECAT HRRT (K040933)Cti Pet Systems, Inc.2004-06-07
21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) (K040695)Totoku Electric Co., Ltd.2004-06-07
BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY (K033859)Barco NV Barcoview2004-06-02
CT COLONOGRAPHY II (K041270)General Electric Medical Systems2004-05-27
CARDIQ ANALYSIS III (K041267)General Electric Medical Systems2004-05-27
IMPAX CLIENT EMBRACE (K040555)Agfa Corp.2004-05-26
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 (K040995)Analogic Corp.2004-05-25
SIMPLANT SYSTEM (K033849)Materialise NV2004-05-25
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (K040378)Eastman Kodak Company2004-05-24
GRIFFIN SPECT/CT IMAGING SYSTEM (K041218)Adac Laboratories2004-05-24
SYNTEGRA (K041182)Adac Laboratories2004-05-21
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS (K040870)Shimadzu Corp.2004-05-17
SIEMENS ENHANCED IMAGING SYSTEM (K041166)Siemens Medical Solutions USA, Inc.2004-05-17
VUE 100 ULTRASOUND IMAGING SYSTEM (K040652)Mobilsonic, Inc.2004-05-17
KMC-950 C-ARM MOBILE SYSTEM (K032761)United Radiology Systems, Inc.2004-05-14
MODIFICATION TO E-SCAN XQ MRI SYSTEM (K041145)Esaote, S.p.A.2004-05-14
NEWTOM 3G QR-DVT 9000 (K041137)Aperio Services, LLC2004-05-14
DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D (K041027)Toshibamedical Systems Corporation2004-05-14
TABLE TILT DEVICE (K033316)Brainlab AG2004-05-14
MINI GAMMA CAMERA, MODEL MGC-500 (K040587)Acrorad Co., Ltd.2004-05-14
TORSO ARRAY COIL, MODEL 558GE-64 (K041185)Igc-Medical Advances, Inc.2004-05-14
COLOR LCD MONITOR, MODEL RADIFORCE R12 (K040982)Eizo Nanao Corporation2004-05-13
IMPAX OT3000 ORTHOPEDIC WORKSTATION (K040344)Agfa Corp.2004-05-12
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D (K040585)Brainlab AG2004-05-11
STANDARD IMAGING E.IMRT CALCULATOR (K040688)Standard Imaging, Inc.2004-05-11
CRADLE PACS (K033912)Cradle Technology Corp.2004-05-11
DXL CALSCAN (K033550)Demetech AB2004-05-05
SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE (K040376)Sectra-Imtec AB2004-05-04
ARTOSCAN C (K040877)Esaote, S.p.A.2004-05-04
PROTOS SOFTWARE (K040709)Aktina Medical Physics Corp.2004-04-28
COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K040365)Barco N.V.2004-04-28
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR (K040804)Southeastern Radiation Products, Inc.2004-04-28
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS (K040546)Tomtec Imaging Systems GmbH2004-04-27
5M MEDICAL FLAT PANEL DISPLAY, ME511L (K031661)Totoku Electric Co., Ltd.2004-04-23
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM (K040884)Hologic, Inc.2004-04-23
TEM 3000 HEAD COIL (K040937)Mr Instruments, Inc.2004-04-23
PREVIEW TREATMENT PLANNING SOFTWARE (K040852)Medical Media Systems, Inc.2004-04-23
CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO (K040468)Cedara Software Corp.2004-04-23
DICOM THEATER (K033153)Ferguson Medical2004-04-23
HITACHI PRESTO (K040902)Hitachi Medical Systems America, Inc.2004-04-21
ENDOSCOUT (K033485)Robin Medical, Inc.2004-04-20
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE (K033006)Barco NV Barcoview2004-04-20
VIATRONIX V3D COLON, REVISION 1.3 (K040126)Viatronix, Inc.2004-04-19
MGD 2621P MEDICAL GREYSCALE DISPLAY (K033104)Barco NV Barcoview2004-04-19
MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY (K033005)Barco NV Barcoview2004-04-19
ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE (K040876)Vital Images, Inc.2004-04-19
SENOGRAPHIC STEREO (K040125)Ge Medical Systems, Inc.2004-04-19
MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY (K033004)Barco NV Barcoview2004-04-16
MGD 2621L MEDICAL GREYSCALE DISPLAY (K033103)Barco NV Barcoview2004-04-16
GE SIGNA 3.0T WITH EXCITE MR SYSTEM (K040444)General Electric Co.2004-04-14
TERATECH MODEL 10V5 SMART PROBE (K040840)Teratech Corp.2004-04-14
MAYO CLINIC BC-10 3.0T (K040122)Mayo Clinic2004-04-14
E-Z SCAN AB5500+ (K040668)Sonomed, Inc.2004-04-13
MFCD 2320 (K040158)Barco N.V.2004-04-12
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM (K040773)Bionix Development Corp.2004-04-09
BRACHYTHERAPY STRAND DEVICE (K040339)Bebig Isotopen-Und Medizintechnik GmbH2004-04-08
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A (K033770)Isoaid, LLC2004-04-08
MODIFICATION TO GE DISCOVERY LS SYSTEM (K040172)GE Medical Systems2004-04-07
CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM (K040195)Witt Biomedical Corp2004-04-07
CADIMPLANT (K040224)Praxim, Inc.2004-04-06
DYNATRAC, COD. 50-1A (K034051)3D Line USA, Inc.2004-04-05
THE CARDIOP-B SYSTEM (K030139)Paieon, Inc.2004-04-02
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