meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
2004-06-10

Clearances · page 84 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041499 SSA-770A, APLIO VERSION 5.5 Toshibamedical Systems Corporation IYN Class II 2004-06-10
K041315 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. IYE Class II 2004-06-10
K040675 AXIOM ARTIS U Siemens Medical Systems, Inc. OWB Class II 2004-06-10
K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. ITX Class II 2004-06-09
K041397 EG-3830UT Pentax Precision Instrument Corp. ITX Class II 2004-06-09
K041395 EG-3630UR Pentax Precision Instrument Corp. ITX Class II 2004-06-09
K041366 IPACS ORTHO Realtimeimage, Inc. LLZ Class II 2004-06-08
K040746 MRA-CMS Medis Medical Imaging Systems BV LLZ Class II 2004-06-08
K041380 IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR R2 Technology, Inc. OEB Class II 2004-06-08
K040933 ECAT HRRT Cti Pet Systems, Inc. KPS Class II 2004-06-07
K040695 21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) Totoku Electric Co., Ltd. LLZ Class II 2004-06-07
K041319 SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2004-06-07
K033859 BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY Barco NV Barcoview LLZ Class II 2004-06-02
K041270 CT COLONOGRAPHY II General Electric Medical Systems LLZ Class II 2004-05-27
K041267 CARDIQ ANALYSIS III General Electric Medical Systems JAK Class II 2004-05-27
K040555 IMPAX CLIENT EMBRACE Agfa Corp. LLZ Class II 2004-05-26
K033849 SIMPLANT SYSTEM Materialise NV LLZ Class II 2004-05-25
K040995 SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 Analogic Corp. KPR Class II 2004-05-25
K040378 KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 Eastman Kodak Company IXA Class II 2004-05-24
K041218 GRIFFIN SPECT/CT IMAGING SYSTEM Adac Laboratories KPS Class II 2004-05-24
K041182 SYNTEGRA Adac Laboratories KPS Class II 2004-05-21
K040870 SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS Shimadzu Corp. JAA Class II 2004-05-17
K040652 VUE 100 ULTRASOUND IMAGING SYSTEM Mobilsonic, Inc. IYO Class II 2004-05-17
K041166 SIEMENS ENHANCED IMAGING SYSTEM Siemens Medical Solutions USA, Inc. KPS Class II 2004-05-17
K041145 MODIFICATION TO E-SCAN XQ MRI SYSTEM Esaote, S.p.A. MOS Class II 2004-05-14
K033316 TABLE TILT DEVICE Brainlab AG JAI Class II 2004-05-14
K041185 TORSO ARRAY COIL, MODEL 558GE-64 Igc-Medical Advances, Inc. MOS Class II 2004-05-14
K040587 MINI GAMMA CAMERA, MODEL MGC-500 Acrorad Co., Ltd. IYX Class I 2004-05-14
K041137 NEWTOM 3G QR-DVT 9000 Aperio Services, LLC OAS Class II 2004-05-14
K032761 KMC-950 C-ARM MOBILE SYSTEM United Radiology Systems, Inc. OWB Class II 2004-05-14
K041027 DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D Toshibamedical Systems Corporation IZI Class II 2004-05-14
K040982 COLOR LCD MONITOR, MODEL RADIFORCE R12 Eizo Nanao Corporation LLZ Class II 2004-05-13
K040344 IMPAX OT3000 ORTHOPEDIC WORKSTATION Agfa Corp. LLZ Class II 2004-05-12
K040585 EXACTRAC 4.0 AND EXACTRAC X-RAY 6D Brainlab AG IYE Class II 2004-05-11
K040688 STANDARD IMAGING E.IMRT CALCULATOR Standard Imaging, Inc. MUJ Class II 2004-05-11
K033912 CRADLE PACS Cradle Technology Corp. LLZ Class II 2004-05-11
K033550 DXL CALSCAN Demetech AB KGI Class II 2004-05-05
K040877 ARTOSCAN C Esaote, S.p.A. LNH Class II 2004-05-04
K040376 SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE Sectra-Imtec AB LLZ Class II 2004-05-04
K040804 .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR Southeastern Radiation Products, Inc. IXI Class II 2004-04-28
K040365 COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. LLZ Class II 2004-04-28
K040709 PROTOS SOFTWARE Aktina Medical Physics Corp. IYE Class II 2004-04-28
K040546 IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS Tomtec Imaging Systems GmbH LLZ Class II 2004-04-27
K040852 PREVIEW TREATMENT PLANNING SOFTWARE Medical Media Systems, Inc. LLZ Class II 2004-04-23
K031661 5M MEDICAL FLAT PANEL DISPLAY, ME511L Totoku Electric Co., Ltd. LLZ Class II 2004-04-23
K040937 TEM 3000 HEAD COIL Mr Instruments, Inc. MOS Class II 2004-04-23
K040884 LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM Hologic, Inc. IZH Class II 2004-04-23
K040468 CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO Cedara Software Corp. LLZ Class II 2004-04-23
K033153 DICOM THEATER Ferguson Medical LLZ Class II 2004-04-23
K040902 HITACHI PRESTO Hitachi Medical Systems America, Inc. JAK Class II 2004-04-21
K033006 MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE Barco NV Barcoview LLZ Class II 2004-04-20
K033485 ENDOSCOUT Robin Medical, Inc. LNH Class II 2004-04-20
K033005 MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY Barco NV Barcoview LLZ Class II 2004-04-19
K040126 VIATRONIX V3D COLON, REVISION 1.3 Viatronix, Inc. LLZ Class II 2004-04-19
K040876 ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE Vital Images, Inc. LLZ Class II 2004-04-19
K040125 SENOGRAPHIC STEREO Ge Medical Systems, Inc. IZH Class II 2004-04-19
K033104 MGD 2621P MEDICAL GREYSCALE DISPLAY Barco NV Barcoview LLZ Class II 2004-04-19
K033103 MGD 2621L MEDICAL GREYSCALE DISPLAY Barco NV Barcoview LLZ Class II 2004-04-16
K033004 MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY Barco NV Barcoview LLZ Class II 2004-04-16
K040122 MAYO CLINIC BC-10 3.0T Mayo Clinic MOS Class II 2004-04-14
K040840 TERATECH MODEL 10V5 SMART PROBE Teratech Corp. ITX Class II 2004-04-14
K040444 GE SIGNA 3.0T WITH EXCITE MR SYSTEM General Electric Co. LNH Class II 2004-04-14
K040668 E-Z SCAN AB5500+ Sonomed, Inc. IYO Class II 2004-04-13
K040158 MFCD 2320 Barco N.V. LLZ Class II 2004-04-12
K040773 PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM Bionix Development Corp. IYE Class II 2004-04-09
K040339 BRACHYTHERAPY STRAND DEVICE Bebig Isotopen-Und Medizintechnik GmbH KXK Class II 2004-04-08
K033770 ISOAID ADVANTAGE PD-103, MODEL IAPD-103A Isoaid, LLC KXK Class II 2004-04-08
K040195 CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM Witt Biomedical Corp LLZ Class II 2004-04-07
K040172 MODIFICATION TO GE DISCOVERY LS SYSTEM GE Medical Systems KPS Class II 2004-04-07
K040224 CADIMPLANT Praxim, Inc. JAK Class II 2004-04-06
K034051 DYNATRAC, COD. 50-1A 3D Line USA, Inc. IYE Class II 2004-04-05
K040665 SOMATOM SENSATION 64 AND SENSATION CARDIAC Siemens Medical Solutions USA, Inc. JAK Class II 2004-04-02
K030139 THE CARDIOP-B SYSTEM Paieon, Inc. IZI Class II 2004-04-02
K040553 MODIFICATION TO ACCULEAF Direx Systems Corp. IXI Class II 2004-04-01
K040596 ULTRASOUND IMAGING SYSTEM, MODEL 7300 Esaote, S.p.A. IYN Class II 2004-03-31
K040041 NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-03-29
K040399 QONTRAST Amid LLZ Class II 2004-03-29
K040040 NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-03-29
K040719 ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY Aloka Co., Ltd. IYO Class II 2004-03-26
K040050 INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 Ge Medical Systems Navigation and Visualization IN LLZ Class II 2004-03-24
K040616 CARDIOMD-AC Danish Diagnostic Development A/S KPS Class II 2004-03-24
K040640 MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL Igc-Medical Advances, Inc. MOS Class II 2004-03-22
K040541 MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 2004-03-22
K040577 SOMATOM PROJECT P30L Siemens Medical Systems, Inc. JAK Class II 2004-03-22
K033955 RTIST Mirada Solutions , Ltd. LLZ Class II 2004-03-17
K033920 CAAS II RVA Pie Medical Imaging BV LLZ Class II 2004-03-17
K040039 NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM Barco N.V. LLZ Class II 2004-03-17
K040486 MEDIPACS Neobit Co., Ltd. LLZ Class II 2004-03-11
K040370 WBR-FHR, WBR-FWB Ultraspect , Ltd. KPS Class II 2004-03-11
K040349 MODIFICATION TO HRW-127 WRIST ARRAY COIL Mri Devices Corp. MOS Class II 2004-03-09
K040347 SIREMOBIL ISO-C 3D Siemens Medical Systems, Inc. OXO Class II 2004-03-09
K034059 SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE Sectra AB LLZ Class II 2004-03-09
K040348 MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL Mri Devices Corp. MOS Class II 2004-03-09
K040502 SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. IYO Class II 2004-03-09
K040288 QSC-127-INT SHOULDER ARRAY COIL SET Mri Devices Corp. MOS Class II 2004-03-05
K033774 CT-MASS Medis Medical Imaging Systems BV JAK Class II 2004-03-02
K040372 LIGHTSPEED 7.0 CT SCANNER SYSTEM Ge Medical Systems, LLC JAK Class II 2004-03-01
K033783 IMALUX OCT IMAGING SYSTEM Imalux Coporation NQQ Class II 2004-03-01
K040192 ON-BOARD IMAGER DEVICE Varian Medical Systems, Inc. IYE Class II 2004-02-27
K040409 LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM Larsen & Toubro Limited IYN Class II 2004-02-27

14,721 clearances in the Radiology panel. Data: openFDA.