meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
22
Latest Decision
2004-09-16

Clearances · page 83 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K042326 ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER Ultrasonix Medical Corporation IYN Class II 2004-09-16
K042328 SOMATOM SPIRIT Siemens Medical Systems, Inc. JAK Class II 2004-09-14
K042313 INTEGRADWEB MPR/MIP Dynamic Imaging, Inc. LLZ Class II 2004-09-09
K042311 PACSPARTNER Medical Standard Co., Ltd. LLZ Class II 2004-09-09
K042293 BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER Philips Medical Systems (Cleveland), Inc. JAK Class II 2004-09-08
K042269 LEKSELL GAMMAPLAN 4C WITH MULTIVIEW Elekta Instrument AB MUJ Class II 2004-09-08
K042292 ISITE PACS Stentor, Inc. LLZ Class II 2004-09-08
K042257 DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION General Electric Co. KPS Class II 2004-09-08
K042008 ULTRAVISUAL Emageon Uv, Inc. LLZ Class II 2004-09-03
K041639 TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM Envisioneering, LLC IYO Class II 2004-09-02
K041638 TARGETSCAN BIOPSY KIT Envisioneering, LLC ITX Class II 2004-09-02
K042229 SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE Siemens Medical Solution, Inc. USA JAK Class II 2004-09-01
K041637 TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM Envisioneering, LLC ITX Class II 2004-09-01
K041508 BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-08-27
K041997 RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE Radionics, A Division of Tyco Healthcare Group LP MUJ Class II 2004-08-27
K041931 OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION Ge Oec Medical Systems, Inc. OWB Class II 2004-08-26
K042053 INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc. OWB Class II 2004-08-26
K041929 MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. JAQ Class II 2004-08-26
K042186 3.0T 8-CHANNEL CTL SPINE ARRAY Usa Instruments, Inc. MOS Class II 2004-08-26
K042207 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL Usa Instruments, Inc. MOS Class II 2004-08-26
K042023 FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER Fujifilm Medical System U.S.A., Inc. MQB Class II 2004-08-25
K041840 MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM Medx, Inc. KPS Class II 2004-08-20
K041933 MICROSELECTRON PDR Nucletron Corp. JAQ Class II 2004-08-18
K041932 OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM Ge Oec Medical Systems, Inc. OWB Class II 2004-08-18
K042055 CYPRESS ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2004-08-16
K041947 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND Innovative Imaging, Inc. IYO Class II 2004-08-16
K041935 DR SYSTEMS PACS, RELEASE 6.1 Dr Systems, Inc. LLZ Class II 2004-08-16
K042103 NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL Mri Devices Corporation MOS Class II 2004-08-16
K041782 SEEMOR 5.0 IMAGE DISPLAY PROGRAM Areeda Assoc., Ltd. LLZ Class II 2004-08-16
K042044 ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2004-08-13
K041266 PEDIATRIC REFERENCE DATABASE Hologic, Inc. KGI Class II 2004-08-11
K041780 NEW BRID Medical Imaging Solutions, Inc. OWB Class II 2004-08-11
K042009 MARK III PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. MOS Class II 2004-08-11
K041555 SECURVIEW DX SOFTCOPY WORKSTATION Hologic, Inc. LLZ Class II 2004-08-09
K041990 FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP Fujifilm Medical System U.S.A., Inc. LLZ Class II 2004-08-06
K033178 ULTRABIO Sonotech, Inc. MUI Class II 2004-08-04
K041915 HEMO-DOP Dwl Elektronische Systeme GmbH IYN Class II 2004-08-04
K041519 MODIFICATION TO: ON-BOARD IMAGER DEVICE Varian Medical Systems, Inc. IYE Class II 2004-08-04
K041949 ALLURA XPER FD10 Philips Medical Systems North America Co. IZI Class II 2004-07-30
K040686 M'ATH STD Intelligence IN Medical Technologies LLZ Class II 2004-07-30
K041916 ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM Aloka Co. Ltd USA IYN Class II 2004-07-30
K041484 UNDECIDED Siemens Medical Solutions USA, Inc. LLZ Class II 2004-07-30
K041955 GEMINI PET/CT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. KPS Class II 2004-07-29
K041922 GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR General Electric Co. IZL Class II 2004-07-28
K041162 ORTHO-CMS Medis Medical Imaging Systems BV LLZ Class II 2004-07-27
K041682 CAAS MRV Pie Medical Imaging BV LLZ Class II 2004-07-27
K041326 MEDCOMMONS OPEN RADIOLOGY GATEWAY Medcommons, Inc. LLZ Class II 2004-07-27
K041921 GE SIGNA PROFILE 6 INCH GP COIL Ge Medical Systems, LLC MOS Class II 2004-07-26
K041403 ECLIPSE WITH AAA Varian Medical Systems MUJ Class II 2004-07-26
K041602 PANORAMA 1.0T Philips Medical Systems North America, Inc. LNH Class II 2004-07-26
K041695 LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE Usa Instruments, Inc. LNH Class II 2004-07-23
K031088 TRIMED PLAN, VERSION 2.2 Trimed Systems, Inc. MUJ Class II 2004-07-23
K041675 PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS Pie Medical IYN Class II 2004-07-23
K041813 GE LOGIQ 7 ULTRASOUND BT04 Ge Medical Systems Ultrasound and Primary Care Dia IYN Class II 2004-07-23
K040931 PATXFER RT Brainlab AG LLZ Class II 2004-07-22
K041807 LUNG CAR 1.1 Medicsight OEB Class II 2004-07-22
K041671 IMAGENMD Cardiovascular Imaging Technologies, LLC KPS Class II 2004-07-22
K041213 3DSCOPE Direx Systems Corp. OXO Class II 2004-07-22
K041719 ONCENTRA-VISIR Nucletron Corp. MUJ Class II 2004-07-22
K040766 OPTISOURCE, MODEL 1032P International Brachytherapy S.A. KXK Class II 2004-07-22
K041701 AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM Agfa Corp. MQB Class II 2004-07-22
K041112 MAGNETOM ESPREE SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2004-07-21
K041286 DYNACAD V1.0 Mri Devices Corp. LNH Class II 2004-07-21
K041481 MODEL BBC-127 BIOPSY BREAST COIL Mri Devices Corp. MOS Class II 2004-07-19
K041111 MAGNETOM C! MR SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2004-07-16
K041702 EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) Ibt SA KXK Class II 2004-07-16
K040896 MODIFICATION TO ENCOMPASS Heartlab, Inc. LLZ Class II 2004-07-16
K041761 RAPIDIACOLON Infinitt Co., Ltd. LLZ Class II 2004-07-13
K041737 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) Totoku Electric Co., Ltd. LLZ Class II 2004-07-13
K041763 SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES Shimadzu Corp. IZL Class II 2004-07-13
K040782 N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX Image Analysis, Inc. JAK Class II 2004-07-13
K041688 GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 General Electric Co. IYN Class II 2004-07-08
K041029 KINETDX Siemens Medi Cal Solutions, Inc. LLZ Class II 2004-07-08
K040970 LEONARDO Siemens Medical Systems, Inc. LLZ Class II 2004-07-08
K041020 CADSTREAM VERSION 3.1 Confirma, Inc. LNH Class II 2004-07-07
K041576 SOURCELINK C.R. Bard, Inc. KXK Class II 2004-07-02
K041552 GE VIVID 7 BT04 General Electric Co. IYN Class II 2004-07-02
K041605 PRECISION RXI ANALOG X-RAY SYSTEM General Medical Merate S.P.A OWB Class II 2004-06-30
K041557 MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W Thomson & Nielsen Electronics, Ltd. IYE Class II 2004-06-25
K041577 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories LNH Class II 2004-06-25
K040687 ONEDOSE PATIENT DOSIMETRY SYSTEM Sicel Technologies, Inc. IYE Class II 2004-06-25
K041597 MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 Eizo Nanao Corporation LLZ Class II 2004-06-24
K040474 ACCUSOFT Direx Systems Corp. MUJ Class II 2004-06-23
K041521 VOLUME VIEWER PLUS General Electric Medical Systems JAK Class II 2004-06-22
K041581 COMPACS, VERSION 1.0 Intelligent Images Srl LLZ Class II 2004-06-22
K041543 GE DISCOVERY ST GE Healthcare KPS Class II 2004-06-22
K041500 STARPACS ORTHOPEDICS SYSTEM Infinitt Co., Ltd. LLZ Class II 2004-06-21
K040704 MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2004-06-18
K041487 QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT Usa Instruments, Inc. MOS Class II 2004-06-17
K041542 CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS Neusoft Digital Medical Systems Co., Ltd. JAK Class II 2004-06-17
K040310 NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS National Display Systems LLZ Class II 2004-06-17
K041476 GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM Ge Medical Systems, LLC LNH Class II 2004-06-17
K041022 NEUROQ - PET DP Syntermed, Inc. KPS Class II 2004-06-17
K041448 HEXAPOD RT COUCHTOP Medical Intelligence Medizintechnik GmbH JAI Class II 2004-06-16
K040443 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I Dome Imaging Systems, Inc. LLZ Class II 2004-06-16
K033960 OLINDA/EXM Vanderbilt University IYX Class I 2004-06-15
K041220 GE DISCOVERY ST SYSTEM GE Medical Systems KPS Class II 2004-06-15
K041455 SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Sonoscape Company Limited IYO Class II 2004-06-10
K040926 ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 Hudson Diagnostic Imaging, LLC IYN Class II 2004-06-10
K040697 21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A) Totoku Electric Co., Ltd. LLZ Class II 2004-06-10

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