meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
1999-10-25

Clearances · page 98 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K992698 STENTOR, PAGEVIEW Stentor, Inc. LMD Class I 1999-10-25
K992603 XRT 600 R/F, WRF 0600 Wuestec Medical, Inc. JAA Class II 1999-10-25
K991280 125 IMPLANT SEEDS, MODEL STM1251 Sourcetech Medical, LLC KXK Class II 1999-10-20
K992580 FETAL ASSESSMENT CAP Acuson Corp. IYO Class II 1999-10-18
K992533 PHILIPS GYROSCAN INTERA (*) Philips Medical Systems North America, Inc. LNH Class II 1999-10-18
K993233 OBC-085 BREAST ARRAY COIL Mri Devices Corp. MOS Class II 1999-10-15
K993235 QWH-085 WRIST ARRAY COIL Mri Devices Corp. MOS Class II 1999-10-15
K990401 FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER Fukuda Denshi USA, Inc. IYO Class II 1999-10-15
K993279 QSC-085 SHOULDER ARRAY COIL Mri Devices Corp. MOS Class II 1999-10-15
K992666 VIDEO PLUS SYSTEM, SERIES 95000 Camtronics, Ltd. LLZ Class II 1999-10-13
K992547 CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 Canon USA, Inc. MQB Class II 1999-10-13
K992426 RAYPAX WEB CLINICAL SYSTEM Samsung Sds Co., Ltd. LMD Class I 1999-10-13
K992354 SNT IMAGE ANALYSIS SYSTEM Surgical Navigation Technologies, Inc. LLZ Class II 1999-10-12
K992650 AIRIS, AIRIS II Hitachi Medical Systems America, Inc. MOS Class II 1999-10-08
K990153 VIRGO MRI SYSTEM Millennium Technology Services LNH Class II 1999-10-08
K992575 CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 Infimed, Inc. LLZ Class II 1999-10-07
K993038 TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) Toshiba America Medical Systems, In.C JAA Class II 1999-10-07
K990990 CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 Nucletron Corp. JAQ Class II 1999-10-07
K992450 EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS Emory University KPS Class II 1999-10-07
K992335 BEACON-P, MODEL 211059 Philips Medical Systems (Cleveland), Inc. KPS Class II 1999-10-07
K983793 PREFERENCE TREATMENT SYSTEM Northwest Medical Physics Equipment, Inc. LNH Class II 1999-10-05
K992262 INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM Indigo Medical, Inc. KXK Class II 1999-10-04
K992775 OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W Hologic, Inc. KGI Class II 1999-10-01
K992317 AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION Adac Laboratories KPS Class II 1999-10-01
K993090 SILHOUETTE FC Ge Medical Systems, Inc. KPR Class II 1999-10-01
K992378 DIAGNOSTIC ULTRASOUND, MODEL 1.0 Volumetrics Medical Imaging, Inc. IYO Class II 1999-09-29
K992352 ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 Inteleradiology, Inc. LMD Class I 1999-09-29
K990241 ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP Accuimage Diagnostics Corp. LLZ Class II 1999-09-23
K992577 PHOTON RADIOSURGERY SYSTEM (PRS) Photoelectron Corporation JAD Class II 1999-09-23
K993069 GE DIASONICS GATEWAY AND GATEWAY FX General Electric Co. IYO Class II 1999-09-22
K992306 SAMSUNG RAYPAX DISPLAY WORKSTATION Samsung Sds Co., Ltd. LLZ Class II 1999-09-22
K991319 RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS Orfit Industries IYE Class II 1999-09-21
K992963 I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 International Isotopes, Inc. KXK Class II 1999-09-21
K992892 STEPPING KINEMATIC IMAGING PLATFORM (SKIP) Magnetic Moments, LLC LNH Class II 1999-09-16
K992131 SAMSUNG RAYPAX LONG TERM ARCHIVE Samsung Sds Co., Ltd. LMB Class I 1999-09-13
K992112 SAMSUNG RAYPAX FILM DIGITIZER Samsung Sds Co., Ltd. LLZ Class II 1999-09-09
K990335 PHILIPS EASYVISION WORKSTATION: Philips Medical Systems North America, Inc. LNH Class II 1999-09-09
K992864 RENDER-PLAN 3-D Precision Therapy Intl., Inc. MUJ Class II 1999-09-09
K992073 AX WORKSTATION Siemens Medical Solutions USA, Inc. LLZ Class II 1999-09-09
K992305 MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 Medi-Stim A/S ITX Class II 1999-09-08
K992135 SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc. LNH Class II 1999-09-08
K992259 ECHOCARDIOGRAPHY SYSTEM SERIES 95000 Camtronics, Ltd. LLZ Class II 1999-09-08
K992225 QUANTITATIVE FLOW Philips Medical Systems (Cleveland), Inc. LNH Class II 1999-09-07
K992677 EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W Hologic, Inc. KGI Class II 1999-09-03
K992193 ENDO-ESOPHAGEAL MR COIL Surgi-Vision, Inc. MOS Class II 1999-09-03
K992246 QCT BONE MINERAL ANALYSIS SOFTWARE Image Analysis, Inc. KGI Class II 1999-09-03
K991966 THE NOMOS CHANE II Nomos Corp. IYE Class II 1999-09-03
K992753 CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM Varian Assoc., Inc. MUJ Class II 1999-09-03
K992280 LORAD 1-650 (INTERNATIONAL 650) Lorad Corp. IZH Class II 1999-09-03
K992896 DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) Dental X-Ray Support Systems, Inc. EGY Class II 1999-09-03
K992078 VANTAGE EXSPECT II Adac Laboratories KPS Class II 1999-09-01
K992818 OPTIMAX/ COMPACT 2 Protec GmbH & Co. KG IXW Class II 1999-09-01
K992761 SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYO Class II 1999-09-01
K992103 C-QUEST Wuestec Medical, Inc. OWB Class II 1999-09-01
K991922 DIGITAL IMAGING SYSTEM (BSR) Siemens Medical Solutions USA, Inc. IZI Class II 1999-09-01
K992066 REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM GE Medical Systems KPR Class II 1999-08-30
K991237 XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL Radionics, Inc. MUJ Class II 1999-08-30
K982208 IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER Jomed Imaging , Ltd. ITX Class II 1999-08-27
K991841 HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA Ge Medical Systems F.I. Haifa KPS Class II 1999-08-26
K992663 ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 1999-08-24
K991943 MRGP OPTICAL TRACKING UNIT Philips Medical Systems (Cleveland), Inc. LNH Class II 1999-08-23
K992470 ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1999-08-23
K991896 MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA Ge Medical Systems F.I. Haifa KPS Class II 1999-08-23
K992506 MINI 6800 DIGITAL MOBILE C-ARM Ge Dec Medical Systems OXO Class II 1999-08-19
K992152 GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF CIVCO Medical Instruments Co., Inc. ITX Class II 1999-08-17
K992412 IPASS BOLUS TRACKING Philips Medical Systems (Cleveland), Inc. LNH Class II 1999-08-17
K990359 KONICA DIRECT DIGITIZER, MODEL DD-341 Konica Corp. MQB Class II 1999-08-17
K991764 SOMATOM PROJECT 10-CT SCANNERS Siemens Medical Solutions USA, Inc. JAK Class II 1999-08-17
K992046 SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 1999-08-13
K992120 DYNAWELL OR DYNAWELL Ekeroth Quality AB LNH Class II 1999-08-13
K991815 EXPLORER 3D Our Scientific Intl., Inc. MUJ Class II 1999-08-13
K991738 DIGITAL VIDEO RECORDING SYSTEM Kay Elemetrics Corp. LLZ Class II 1999-08-13
K991826 PLANMED SOPHIE AND SOPHIE CLASSIC Planmed OY IZH Class II 1999-08-10
K991766 ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A Toshiba America Medical Systems, In.C JAK Class II 1999-08-10
K984532 CADPLAN HELIOS OPTION 6.0 Varian Medical Systems, Inc. MUJ Class II 1999-08-09
K992229 MXU-125 OR TMX-125 Trex Medical Corp. IZL Class II 1999-08-06
K991652 HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM Siemens Corp. LNH Class II 1999-08-03
K991724 QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 Medical Advances, Inc. MOS Class II 1999-08-02
K991740 OPART, MODEL MRT-600 Toshiba America Mri, Inc. MOS Class II 1999-08-02
K991629 GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C Ge Medical Systems, Inc. LLZ Class II 1999-08-02
K991565 TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S Smv America KPS Class II 1999-08-02
K991805 ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION Acuson Corp. IYN Class II 1999-08-02
K991765 SYNERGY SHOULDER COIL Philips Medical Systems North America, Inc. MOS Class II 1999-08-02
K991535 CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS Hitachi Medical Corp. of America KPS Class II 1999-07-30
K992037 MAMEX Del Medical Imaging Corp. IZH Class II 1999-07-30
K991523 TLC PEDIATRIC FRAME, MODEL TLC-SYS Radionics, Inc. IYE Class II 1999-07-30
K991546 AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD Aktina Medical Physics Corp. IYE Class II 1999-07-30
K991937 ULTRASOUND SCANNER, MODEL TYPE 2101 B & K Medical A/S IYO Class II 1999-07-30
K991607 VANTAGE 2.5 Adac Laboratories KPS Class II 1999-07-26
K991469 AWARE PAD Aac Consulting Group, Inc. IYO Class II 1999-07-20
K991568 MR SPECTROSCOPY PACKAGE Philips Medical Systems (Cleveland), Inc. LNI Class II 1999-07-19
K984563 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. IWB Class II 1999-07-14
K983660 EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) Brainlab, Inc. LHN Class II 1999-07-14
K984639 THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER Medison America, Inc. ITX Class II 1999-07-12
K991336 BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY Medical Instrumentation & Diagnostics Corp.(Midco) IYE Class II 1999-07-12
K992208 GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical Systems, Inc. IYO Class II 1999-07-12
K992155 VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 Medison America, Inc. ITX Class II 1999-07-08
K991434 QUADRATURE WRIST COIL, MODEL 445PH-64 Medical Advances, Inc. MOS Class II 1999-07-06
K991537 SAMSUNG RAYPAX SYSTEM Samsung Sds Co., Ltd. LMD Class I 1999-07-06
K991468 IMMERGE IMAGE CORRELATION Surgical Navigation Technologies, Inc. LLZ Class II 1999-07-06

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