meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
2002-11-21

Clearances · page 89 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K022860 ATLANTIS PV IMAGING CATHETER, MODEL 36456 Boston Scientific, Target ITX Class II 2002-11-21
K023003 IMAGECHECKER-CT WORKSTATION R2 Technology, Inc. LLZ Class II 2002-11-20
K023720 SONOLINE ANTARES ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2002-11-20
K023473 SONOREAL 3D Bio Medi Com IYO Class II 2002-11-20
K023571 6 CHANNEL BODY COIL Siemens Medical Systems, Inc. MOS Class II 2002-11-20
K013694 NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) Nidek, Inc. NFJ Class II 2002-11-19
K023679 GORE 3.0T TORSO ARRAY W. L. Gore & Associates, Inc. MOS Class II 2002-11-18
K023008 UNIVERSAL SYSTEM, MODEL QV-800 Quantum Medical Imaging, LLC KPR Class II 2002-11-13
K022708 KLARITY Larson Products, Inc. IYE Class II 2002-11-12
K023518 ECAT LSO PET/CT 16 Cti Pet Systems, Inc. KPS Class II 2002-11-08
K023596 MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL Medrad, Inc. MOS Class II 2002-11-08
K023398 HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY Hologic, Inc. KGI Class II 2002-11-08
K023557 CENTRICITY PACS PLUS GE Medical Systems LLZ Class II 2002-11-07
K023442 EXTRA LARGE BODY COIL GE Medical Systems MOS Class II 2002-11-05
K023511 EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 Toshiba America Medical Systems, In.C LNH Class II 2002-11-05
K023586 DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS Canon USA, Inc. MQB Class II 2002-11-05
K022036 SIEMENS VIRTUAL SIMULATION (VSIM) Siemens Medical Solutions USA, Inc. MUJ Class II 2002-11-05
K022007 LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES Usa Instruments, Inc. MOS Class II 2002-11-04
K023457 ULTRASOUND SCANNER, TYPE 1101 B-K Medical A/S IYO Class II 2002-11-01
K023441 PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems IZI Class II 2002-10-30
K023440 PHILIPS DIGITAL IMAGING OPTION RELEASE 1 Philips Medical Systems LLZ Class II 2002-10-30
K022739 REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 Nucletron Corporation JAQ Class II 2002-10-25
K023220 VARISOURCE BREAST TEMPLATE SYSTEM Varian Medical Systems JAQ Class II 2002-10-25
K022788 PHILIPS HARMONY RELEASE 1 Philips Medical Systems North America Co. LLZ Class II 2002-10-25
K022938 VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 Volume Interactions Pte, Ltd. LLZ Class II 2002-10-25
K022741 SPOT PRO (220V), MODEL 131.099 Nucletron Corporation MUJ Class II 2002-10-24
K023190 E.CAM COMPUTER / E.SOFT WORKSTATION Siemens Medical Solutions USA, Inc. LLZ Class II 2002-10-24
K023332 LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW GE Medical Systems JAK Class II 2002-10-23
K022582 EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL Usa Instruments, Inc. MOS Class II 2002-10-22
K023287 DRYSTAR 5500 Agfa Corp. LMC Class II 2002-10-22
K022881 CEDARA I-SOFTVIEW Cedara Software Corp. LLZ Class II 2002-10-22
K022737 HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC Health Care Mfg., Inc. KPR Class II 2002-10-22
K022667 HCMI X-RAY Health Care Mfg., Inc. KPR Class II 2002-10-22
K022824 ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X Tomtec Imaging Systems GmbH LLZ Class II 2002-10-17
K022710 SMARTPACS Taiwan Electronic Data Processing Corporation LLZ Class II 2002-10-11
K022692 VOXELPLUS PACS Mevisys Co., Ltd. LLZ Class II 2002-10-11
K022390 HITACHI ALTAIRE Hitachi Medical Systems America, Inc. LNH Class II 2002-10-11
K023130 ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM Mri Devices Corp. LNH Class II 2002-10-11
K023061 KONICA DIRECT DIGITIZER REGIUS, MODEL 170 Konica Minolta Medical & Graphic, Inc. MQB Class II 2002-10-11
K022940 IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0 Intelligent Images Srl LLZ Class II 2002-10-11
K022810 COBRASCAN CR-1 FILMLESS Radiographic Digital Imaging, Inc. LMA Class II 2002-10-11
K022585 KIMAX QMA Medical Metrics, Inc. LLZ Class II 2002-10-11
K023100 ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS General Electric Medical Systems Information Techn LLZ Class II 2002-10-11
K023052 ACUITY RADIATION THERAPY SIMULATOR Varian Medical Systems, Inc. KPQ Class II 2002-10-11
K022794 E-SPEED EBT SCANNER SYSTEM Ge Imatron JAK Class II 2002-10-11
K023164 BBC-63-GE BREAST ARRAY COIL Mri Devices Corp. MOS Class II 2002-10-11
K022342 EZ-SCOPE AN, EZ-SCOPE LIGHT Anzai Medical Co., Ltd. IYX Class I 2002-10-09
K023207 OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) Toshiba America Medical Systems, In.C LNH Class II 2002-10-09
K022322 INNOVA AND INNOVA 2000 S Ge Medical Systems, Inc. OWB Class II 2002-10-08
K022307 KONRAD, MODEL V.2.0 Mrc Systems GmbH MUJ Class II 2002-10-08
K022565 TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 Stereotaxis, Inc. JAA Class II 2002-10-08
K021333 ARTEMIS Ultralink, LLC IYO Class II 2002-10-08
K020027 FOCUS RADIATION TREATMENT PLANNING SYSTEM Computerized Medical Systems, Inc. MUJ Class II 2002-10-08
K022219 EXOMIO, MODEL 1.1 Medcom GmbH KPQ Class II 2002-10-07
K023124 CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT Canon, Inc. MQB Class II 2002-10-04
K022896 CSV12 SOFTWARE VIEWER Acuson Corp. LLZ Class II 2002-10-03
K022910 QSC-63-INT SHOULDER ARRAY COIL SET Mri Devices Corp. MOS Class II 2002-10-03
K011493 MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY Mentor Corp. KPT Class II 2002-10-01
K022154 LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D Fischer Industries, Inc. IXW Class II 2002-09-30
K013875 MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE Med-Tec,Inc. IXI Class II 2002-09-27
K022883 HRK-63 KNEE ARRAY COIL Mri Devices Corp. MOS Class II 2002-09-27
K023024 TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 Vascular Control Systems, Inc. ITX Class II 2002-09-26
K023020 AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE Agfa Corp. IXA Class II 2002-09-26
K022411 PRECISEPLAN 2.0 Precision Therapy Intl., Inc. MUJ Class II 2002-09-20
K022919 SMART BREATH RESPIRATORY COMPENSATION OPTION GE Medical Systems JAK Class II 2002-09-19
K022960 GE QUASAR NUCLEAR MEDICINE SYSTEM Ge Medical Systems F.I. Haifa KPS Class II 2002-09-19
K022114 IMPERIUM Elmstech, Inc. OWB Class II 2002-09-17
K022069 OEC FLUOROTRAK 9800 PLUS Ge Oec Medical Systems OWB Class II 2002-09-17
K022292 IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO Agfa Corp. LLZ Class II 2002-09-12
K022275 DELTA 32; DELTA 32 TACT Instrumentarium Corp. Imaging Division IZH Class II 2002-09-12
K013644 ACQPLAN 5.0 Philips Medical Systems, Inc. MUJ Class II 2002-09-12
K022872 GE ROAD WARRIOR PET CT IMAGING SYSTEM General Electric Co. KPS Class II 2002-09-12
K020624 BREAST BOLSTER Beekley Corp. IZH Class II 2002-09-12
K022635 KUSKE BREAST APPLICATOR SET, MODEL 189.006 Nucletron Corporation JAQ Class II 2002-09-06
K022649 COOK-SWARTZ DOPPLER FLOW PROBE Cook Vascular, Inc. ITX Class II 2002-09-06
K022720 CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL Mri Devices Corp. MOS Class II 2002-09-06
K022858 SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM Novasonics, Inc. IYN Class II 2002-09-06
K021913 CALSCOR SOFTWARE 3D Med Co., Ltd. LLZ Class II 2002-09-06
K022669 8 CHANNEL CARDIAC PHASED ARRAY COIL GE Medical Systems MOS Class II 2002-09-06
K022789 VIATRONIX V3D EXPLORER Viatronix, Inc. LLZ Class II 2002-09-06
K022658 LR DICOM CONTROLLER Agfa Corp. LMC Class II 2002-09-06
K022588 HRW-63-INT WRIST ARRAY COIL Mri Devices Corp. MOS Class II 2002-09-04
K022157 RF TENT Odin Medical Technologies , Ltd. LNH Class II 2002-08-28
K020320 RADIOSYSTEM/NT, MODEL 80-13020 Styker Instruments IYE Class II 2002-08-28
K022487 MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL Mri Devices Corp. MOS Class II 2002-08-23
K022488 MODEL OBC-63 BREAST ARRAY COIL Mri Devices Corp. MOS Class II 2002-08-23
K022239 SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM Praxim JAK Class II 2002-08-23
K022397 SIGNA 3.0T MAGNETIC RESONANCE SYSTEM GE Medical Systems LNH Class II 2002-08-22
K021738 FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES Totoku Electric Co., Ltd. LLZ Class II 2002-08-19
K021751 ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc. MOS Class II 2002-08-15
K022153 BLADDERSCAN BVI 6100 Diagnostic Ultrasound Corp. IYO Class II 2002-08-15
K021633 ECAT VISION PET SCANNER, MODELS 3000 & 5000 Cti Pet Systems, Inc. KPS Class II 2002-08-14
K022337 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D Siemens Medical Solutions USA, Inc. IZL Class II 2002-08-13
K022395 1.5T SCANMED PV ARRAY Medic, Inc. MOS Class II 2002-08-13
K022372 HRH-127-8 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2002-08-13
K021631 ISA-21 INTERVENTIONAL SPINE ARRAY COIL Mri Devices Corp. MOS Class II 2002-08-13
K022354 ULTRAGUIDE CTG 2000SA Ultraguide , Ltd. JAK Class II 2002-08-13
K022567 SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM Acuson Corp. IYN Class II 2002-08-13
K021934 MODIFICATION TO MEDSTATION Aisoftw@Re Medical, S.P.A. LLZ Class II 2002-08-12
K021949 FULCRUM Howtek, Inc. LMA Class II 2002-08-12

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