meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
24
Latest Decision
2000-03-09

Clearances · page 97 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993946 PEGASYS ULTRA Adac Laboratories LLZ Class II 2000-03-09
K994378 AIRIS II Hitachi Medical Systems America, Inc. MOS Class II 2000-03-07
K994167 CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) Ge Medical Systems F.I. Haifa KPS Class II 2000-03-07
K994282 MRI- FLOW ANALYTICAL SOFTWARE PACKAGE Medis Medical Imaging Systems BV LNH Class II 2000-03-02
K000034 OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM Optimal Imaging Systems, Inc. IYN Class II 2000-02-24
K994369 7250 (MEGAS) Biosound Esaote, Inc. IYN Class II 2000-02-24
K000002 MAGNA 5000 PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2000-02-23
K994228 REMOTEIMAGE SYSTEM Etrauma.Com Corp. LLZ Class II 2000-02-22
K991571 10 CURIE IRDIUM 192, CSN00100-192 Alpha-Omega Services, Inc. KXK Class II 2000-02-22
K000159 AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO Agfa Corp. IXK Class II 2000-02-16
K992751 SOMAVISION Varian Assoc., Inc. KPQ Class II 2000-02-16
K000300 LIGHTSPEED 2.0CT SCANNER SYSTEM Ge Medical Systems, Inc. JAK Class II 2000-02-15
K994054 ISSA PHAROS Vams Tec, D.O.O. LLZ Class II 2000-02-14
K993959 ISOCENTRIC BEAM CHECKER Mick Radio-Nuclear Instruments, Inc. IYE Class II 2000-02-14
K993037 LCV+ VERSION 2 Ge Medical Systems, Inc. OWB Class II 2000-02-14
K993960 PERMA-DOC PHANTOM Mick Radio-Nuclear Instruments, Inc. IYE Class II 2000-02-14
K994345 MAGNA 5000 PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2000-02-14
K993861 FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER Fujifilm Medical System U.S.A., Inc. MQB Class II 2000-02-10
K000052 X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 Dynarad Corp. ITY Class I 2000-02-10
K992689 MU PLUS Rad Therapy Solutions, Inc. IYE Class II 2000-02-10
K993893 MEDX INTECAM INTERFACE Medx, Inc. KPS Class II 2000-02-10
K992467 IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM Dba Systems, Inc. LMA Class II 2000-02-10
K993978 PR3 ULTRASOUND SYSTEM Carolina Medical, Inc. IYO Class II 2000-02-10
K993803 EXCELART WITH PIANISSIMO Toshiba America Mri, Inc. LNH Class II 2000-02-06
K994210 INTURIS SUITE Philips Medical Systems, Inc. LLZ Class II 2000-02-04
K993898 KAC-63 KNEE ARRAY COIL Mri Devices Corp. MOS Class II 2000-02-04
K000015 BARCOMED 2MP2 Barco N.V. LLZ Class II 2000-02-04
K994315 CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc. MOS Class II 2000-02-04
K994117 MR ENHANCER I.Z.I. Corp. LNH Class II 2000-02-04
K993742 SUPER TISSUE I.Z.I. Corp. IYE Class II 2000-02-02
K993750 PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO Problem Solving Concepts, Inc. LLZ Class II 2000-02-02
K994042 SHARP 9000 PHASED ARRAY BRAIN COIL Usa Instruments, Inc. MOS Class II 2000-01-31
K993598 MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 Vidar Systems Corp. LMA Class II 2000-01-20
K993682 MRI EQUIPMENT COVER Image-Guided Neurologics, Inc. LNH Class II 2000-01-20
K000030 SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYO Class II 2000-01-19
K993599 DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 Vidar Systems Corp. LMA Class II 2000-01-18
K994040 PHASED ARRAY KNEE AND FOOT COIL Usa Instruments, Inc. MOS Class II 2000-01-18
K993574 OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON Toshiba America Mri, Inc. LNH Class II 2000-01-18
K993802 SHARPVIEW IMAGE ENHANCEMENT SYSTEM Context Vision AB LLZ Class II 2000-01-18
K993813 LUMAGEM SCINTILLATION CAMERA Gamma Medica IYX Class I 2000-01-18
K992007 PHARMASEED, MODEL BT-103-1 Syncor Pharmaceuticals, Inc. KXK Class II 2000-01-14
K994316 MAGNETOM OPEN VIVA WITH PERMANENT MAGNET Siemens Medical Corp. LNH Class II 2000-01-14
K992434 ITP, MODEL 1.0 Nucletron Corp. MUJ Class II 2000-01-13
K993472 SEGMENTED VAGINAL APPLICATOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2000-01-12
K993522 AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT Aktina Medical Physics Corp. JAI Class II 2000-01-10
K993400 HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2000-01-06
K993283 OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C Arnold & Richter Cine Technik LLZ Class II 1999-12-29
K993338 INTEGRATED DIGITAL MEDICAL RECORD (IDMR) Ibm Israel , Ltd. LLZ Class II 1999-12-29
K993761 CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW Medis Medical Imaging Systems BV LLZ Class II 1999-12-28
K992008 PHARMASEED, MODEL BT-125-1 Syncor Pharmaceuticals, Inc. KXK Class II 1999-12-23
K993731 SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 1999-12-23
K993962 PENSIL TRAUMA, MODEL WWS6100 Wuestec Medical, Inc. KPR Class II 1999-12-21
K993947 KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY Siemens Corp. IZI Class II 1999-12-21
K993645 CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM Ge Medical Systems, Inc. JAK Class II 1999-12-21
K993681 DIGITEC TWO STAGE COMPRESSION KIT Digitec Medical Service Corp. IZH Class II 1999-12-21
K993687 UROVIEW 2800 Ge Dec Medical Systems OWB Class II 1999-12-21
K993227 PHILIPS INTURIS DICOM RECORDER Philips Medical Systems North America, Inc. LLZ Class II 1999-12-21
K993359 RAPTOR TREATMENT PLANNING SYSTEM Nomos Corp. IYE Class II 1999-12-21
K994096 SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM Sonosite,Inc. IYN Class II 1999-12-20
K993597 PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 Vidar Systems Corp. LMA Class II 1999-12-15
K993594 CONFORMAX MMLC VR1 Radionics, Inc. IYE Class II 1999-12-15
K993530 SYSTEM 2100 Math Solutions, LLC LLZ Class II 1999-12-15
K993532 DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) Impax Technology, Inc. LLZ Class II 1999-12-15
K993766 HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM Helax AB MUJ Class II 1999-12-08
K990329 PHILIPS EASYVISION WORKSTATION Philips Medical Systems North America, Inc. LNH Class II 1999-12-07
K993819 QWH-300 WRIST ARRAY COIL Mri Devices Corp. MOS Class II 1999-12-03
K993776 OBC-300 BREAST ARRAY COIL Mri Devices Corp. MOS Class II 1999-12-03
K992992 AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A Toshiba America Medical Systems, In.C KPS Class II 1999-12-03
K993719 KAC-300 KNEE ARRAY COIL Mri Devices Corp. MOS Class II 1999-11-26
K993765 QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) Medis Medical Imaging Systems BV IZI Class II 1999-11-26
K993425 PRIMUS Siemens Medical Solutions USA, Inc. IYE Class II 1999-11-26
K993740 MAMEX Medical Systems Group IZH Class II 1999-11-26
K993763 QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) Medis Medical Imaging Systems BV IZI Class II 1999-11-26
K993780 QSC-300 SHOULDER ARRAY COILS Mri Devices Corp. MOS Class II 1999-11-26
K993792 SMART VESSEL ANALYSIS (SMART VA) OPTION Ge Medical Systems, Inc. JAK Class II 1999-11-24
K993791 CT PERFUSION OPTION Ge Medical Systems, Inc. JAK Class II 1999-11-24
K992925 AX WORKSTATION DR-VIEWER SOFTWARE OPTION Siemens Corp. LLZ Class II 1999-11-23
K992125 XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 Norland Medical Systems, Inc. KGI Class II 1999-11-22
K990475 TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 Kps & Assoc., Inc. MUJ Class II 1999-11-18
K993665 LEGEND CRF FLUORO AND RAD SYSTEM Ge Medical Systems, Inc. KPR Class II 1999-11-12
K992505 TERATECH, MODEL 2000 IMAGING IMAGING Teratech Corp. IYO Class II 1999-11-10
K993624 SITE-RITE 3 ULTRASOUND SYSTEM Dymax Corp IYO Class II 1999-11-10
K992731 E.CAM COMPUTER Siemens Medical Solutions USA, Inc. KPS Class II 1999-11-10
K992740 EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS Imatron, Inc. JAK Class II 1999-11-09
K992794 STINGRAY DR, MODEL 1 Infimed, Inc. MQB Class II 1999-11-09
K992886 POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A Toshiba America Medical Systems, In.C LLZ Class II 1999-11-09
K992746 SIGNA HFO/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc. LNH Class II 1999-11-09
K993394 ECHO SCAN, EASY SCAN Tomtec Imaging Systems GmbH IYO Class II 1999-11-05
K992654 PLUG 'N VIEW 3D, VERSION 1.0 Voxar Limited LLZ Class II 1999-11-05
K993364 GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION Ge Medical Systems, Inc. IYO Class II 1999-11-05
K992660 URF DIGITAL - OT Siemens Medical Solutions USA, Inc. OWB Class II 1999-11-05
K991344 WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS Worldwide Medical Technologies, LLC KXK Class II 1999-11-05
K993365 GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION Ge Medical Systems, Inc. IYO Class II 1999-11-05
K993398 ECHO VIEW, EASY VIEW, OMNI VIEW Tomtec Imaging Systems GmbH IYO Class II 1999-11-05
K993517 COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION Medison America, Inc. IYO Class II 1999-11-02
K990826 INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 1999-11-01
K993477 HRW WRIST ARRAY COIL Mri Devices Corp. MOS Class II 1999-11-01
K984203 SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM Shantou Institute of Ultrasonic Instuments IYN Class II 1999-11-01
K992560 MAPS 10000 Web Link Medical KPS Class II 1999-10-29
K992586 KONICA LASER IMAGER, DRYPRO MODEL 722 Konica Corp. LMC Class II 1999-10-29

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