meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
22
Latest Decision
2003-07-23

Clearances · page 87 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K031222 SCANLUBE Sonotech, Inc. MUI Class II 2003-07-23
K032114 SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2003-07-21
K031597 DUNLEE FORMAT COLLIMATOR FAMILY Philips Medical Systems North America Co. IZW Class II 2003-07-21
K032135 SITE-RITE IV ULTRASOUND SYSTEM Dymax Corp IYO Class II 2003-07-21
K031638 CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION Electromed Imaging, Inc. LLZ Class II 2003-07-21
K031536 BRAIN COIL, MODEL 9900GE-64 Clinical MR Solutions, LLC MOS Class II 2003-07-18
K031631 STEREOTACTIC BODY FRAME, MODEL COD. 70-1A 3D Line USA, Inc. IYE Class II 2003-07-18
K032111 ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2003-07-18
K031365 PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc. MOS Class II 2003-07-18
K031874 MODIFICATION TO WBR, MODEL HR U.C.G. Technologies , Ltd. KPS Class II 2003-07-18
K031894 SCANTEC PAD Sonotech, Inc. MUI Class II 2003-07-18
K032096 PHILIPS VIEWFORUM 2003 Philips Medical Systems LLZ Class II 2003-07-18
K032046 PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc. OWB Class II 2003-07-17
K031273 AMERITEK SURE-POINT HDR NEEDLE TEMPLATE Amertek Medical, Inc. JAQ Class II 2003-07-15
K031119 MAYO CLINIC BC-10 1.5T Mayo Medical Ventures MOS Class II 2003-07-15
K031366 PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2003-07-11
K032036 GEMINI 16 Philips Medical Systems (Cleveland), Inc. KPS Class II 2003-07-11
K031929 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION Wide Corporation LLZ Class II 2003-07-08
K023179 READI-STRAND, MODEL PSSTRAND Worldwide Medical Technologies, LLC KXK Class II 2003-07-02
K031927 GE DELTA SOFTWARE OPTION FOR MRI GE Medical Systems LNH Class II 2003-07-02
K031372 PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION Maxxvision, LLC LLZ Class II 2003-07-02
K031886 SONOVIEW PRO BY MEDISON CO., LTD. Medison Co., Ltd. LLZ Class II 2003-06-30
K030981 ECLIPSE Varian Medical Systems, Inc. LNH Class II 2003-06-24
K023430 UF BRACHYTHERAPY STAND University of Florida IYO Class II 2003-06-24
K031350 3TP SOFTWARE OPTION 3tp, LLC LNH Class II 2003-06-23
K031871 AUTOBONE Ge Medical Systems Europe JAK Class II 2003-06-20
K031198 SCANX 10 Air Techniques, Inc. MQB Class II 2003-06-20
K031872 ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] Adac Laboratories KPS Class II 2003-06-20
K031311 INTEGRADWEB BY DYNAMIC IMAGING, INC. Dynamic Imaging, Inc. LLZ Class II 2003-06-20
K030330 CTXA HIP EXTENDED REFERENCE DATA Mindways Software, Inc. KGI Class II 2003-06-20
K031095 SENSE BODY COIL Philips Medical Systems (Cleveland), Inc. MOS Class II 2003-06-20
K031825 C.CAM Danish Diagnostic Development A/S KPS Class II 2003-06-20
K031391 HF MODULE WITH TRANSDUCERS Ophthalmic Technologies, Inc. IYO Class II 2003-06-20
K031248 CONSULTIVA REPORT STATION, MODEL RS-1 Miramedica, Inc. LLZ Class II 2003-06-20
K031535 PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co. KPR Class II 2003-06-17
K031705 SKYLIGHT IMAGING SYSTEM Adac Laboratories KPS Class II 2003-06-17
K031633 CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C Canon USA, Inc. MQB Class II 2003-06-11
K021360 SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 Med-Tec,Inc. KXK Class II 2003-06-10
K031663 GE VIVID 7, MODEL FC0003XX General Electric Co. IYN Class II 2003-06-09
K022705 READI-STRAND, MODEL PSSTRAND Worldwide Medical Technologies, LLC KXK Class II 2003-06-09
K031552 MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS Medison America, Inc. IYN Class II 2003-05-30
K031172 SPIRIT III TOTALSENSE CARDIAC COIL Usa Instruments, Inc. MOS Class II 2003-05-29
K031143 ALPHA 5000 WRIST COIL Usa Instruments, Inc. MOS Class II 2003-05-29
K030781 KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB Eastman Kodak Company LLZ Class II 2003-05-29
K031139 PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2003-05-29
K030751 IPACS PRISM Realtimeimage, Inc. LLZ Class II 2003-05-29
K030889 ULTRAEKOGEL MODELS EK 2000 & EK 2001 Inmed Ltda. MUI Class II 2003-05-23
K031209 GE 1.5T 8 CHANNEL TORSO COIL Ge Medical Systems, Inc. MOS Class II 2003-05-23
K030728 FYRELINK VL Mpacs, LLC LLZ Class II 2003-05-23
K031469 AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 Toshiba America Medical Systems, In.C JAK Class II 2003-05-22
K030544 RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM Sigma Vision, Inc. OWB Class II 2003-05-21
K031206 RADIOMED SOFT TISSUE MARKER Radiomed Corp. JAK Class II 2003-05-21
K030558 MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. JAQ Class II 2003-05-21
K030534 VARISEED 7.1 Varian Medical Systems KXK Class II 2003-05-21
K031447 CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G Canon, Inc. MQB Class II 2003-05-21
K030494 SR-130 Source-Ray, Inc. IZL Class II 2003-05-20
K030518 AMERITEK SURE-POINT TRACKER SYSTEM Amertek Medical, Inc. ITX Class II 2003-05-20
K031396 ADVANTAGE WORKSTATION PASTING 1.1 GE Medical Systems LNH Class II 2003-05-13
K031333 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc. IZI Class II 2003-05-13
K031358 TRANSVAGINAL DOPPLER PROBE Vascular Control Systems, Inc. ITX Class II 2003-05-09
K031089 GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY W. L. Gore & Associates, Inc. MOS Class II 2003-05-08
K031056 MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2003-05-08
K030439 HEADFIX Medical Intelligence Medizintechnik GmbH IYE Class II 2003-05-08
K030450 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH J. Morita USA, Inc. JAK Class II 2003-05-06
K031261 CARD EP GE Medical Systems JAK Class II 2003-05-06
K022389 READI-LOAD SYSTEM, MODEL PSS 1820RL Worldwide Medical Technologies, LLC KXK Class II 2003-05-06
K023943 CT COLONOGRAPHY Ge Medical Systems, Inc. JAK Class II 2003-05-06
K030371 PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc. MOS Class II 2003-05-05
K030347 20.1 MONOCHROME LCD MONITOR, RADIFORCE G20 Eizo Nanao Corporation LLZ Class II 2003-05-02
K031230 GE PROPELLER IMAGING OPTION FOR MRI GE Medical Systems LNH Class II 2003-05-02
K030690 CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS Codonics, Inc. LMC Class II 2003-04-30
K030274 MEDICAL FLAT PANEL DISPLAY, ME315L Totoku Electric Co., Ltd. LLZ Class II 2003-04-25
K030272 FLAT PANEL DISPLAY, ME183L Totoku Electric Co., Ltd. LLZ Class II 2003-04-25
K030276 FLAT PANEL DISPLAYS, CDL SERIES Totoku Electric Co., Ltd. LLZ Class II 2003-04-25
K024342 RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 Daito Co., Ltd. IXW Class II 2003-04-23
K020754 NICOLET PIONEER TC8080 Nicolet Biomedical IYN Class II 2003-04-21
K030175 2 BASIC Capintec, Inc. IYE Class II 2003-04-17
K030934 GE LOGIQ 9 MODEL 2375600 Ge Medical Systems, Inc. IYN Class II 2003-04-17
K031013 INFINTT CO., LTD. STARPACS SYSTEM Infinitt Company LLZ Class II 2003-04-17
K030540 HTS ARRAY COIL Jockey Club Mri Engineering Center MOS Class II 2003-04-16
K030594 I-125 RAPID STRAND, MODEL 7000 Amersham Health KXK Class II 2003-04-10
K030953 GE 3.0T GENERAL PURPOSE FLEX COIL Ge Medical Systems, Inc. MOS Class II 2003-04-10
K030870 WBR, MODEL HR U.C.G. Technologies , Ltd. KPS Class II 2003-04-09
K030457 REX, VERSION 3.0 Pointdx, Inc. LLZ Class II 2003-04-08
K030982 SYNGO COLONOGRAPHY SOFTWARE PACKAGE Siemens Medical Solutions USA, Inc. LLZ Class II 2003-04-08
K023073 SEED LINK Implant Sciences Corp. KXK Class II 2003-04-07
K030061 PS 3000 DIGATAL PHOTOSPOT SYSTEM Precise Optics OWB Class II 2003-04-07
K030949 TITAN HIGH RESOLUTION ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2003-04-07
K030051 VERSABOARD, MODEL 7040 Bionix Development Corp. IYE Class II 2003-04-04
K030110 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2003-04-03
K030918 SUPEROPEN 0.35T, MODEL NSM-P035 Neusoft Digital Medical Systems Co., Ltd. LNH Class II 2003-04-01
K030162 LAWRENCE CSERION, MODEL CS-1 Isoray, Inc. KXK Class II 2003-03-28
K030635 THE OBSIDIAN PACS SYSTEM Obsidian Medical Technology, Inc. LLZ Class II 2003-03-28
K030874 GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM General Electric Co. LNH Class II 2003-03-28
K023210 SEEDLINKS, MODELS 70301, 70302, 70303 Sourcetech Medical, LLC KXK Class II 2003-03-28
K030770 OTI SCAN WITH TRANSDUCERS Ophthalmic Technologies, Inc. IYO Class II 2003-03-27
K030363 ORG@NIZER, MODEL VERSION 3.0 Ebit Sanita, S.P.A. LLZ Class II 2003-03-27
K030763 DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM Diagnostic Ultrasound Corp. IYO Class II 2003-03-26
K030666 MULTICARE PLATINUM SYSTEM AND ACCESSORIES Lorad, A Hologic Co. IZH Class II 2003-03-25
K024358 20.1 MONOCHROME LCD MONITOR, RADIFORCE G21 Eizo Nanao Corporation LLZ Class II 2003-03-25

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