meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2001-11-08

Clearances · page 92 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012844 MAROSIS PACS Marotech, Inc. LLZ Class II 2001-11-08
K013521 GEMINI IMAGING SYSTEM Adac Laboratories JAK Class II 2001-11-07
K013522 SOMATOM P30 CT SYSTEMS Siemens Medical Systems, Inc. JAK Class II 2001-11-07
K013531 QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 Impac Medical Systems, Inc. KPQ Class II 2001-11-07
K013496 MODIFICATION TO SKYLIGHT IMAGING SYSTEM Adac Laboratories KPS Class II 2001-11-06
K012779 ICONNECTION 3D Hinnovation, Inc. LLZ Class II 2001-11-02
K012546 OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM Sedecal USA, Inc. KPR Class II 2001-11-02
K013481 DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION GE Medical Systems KPR Class II 2001-11-02
K012563 DEEP GRAY Cortechs Labs, Inc. LLZ Class II 2001-11-02
K012495 OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS Siemens Medical Solutions USA, Inc. LNH Class II 2001-10-31
K013504 MODIFICATION TO: ECAT LSO PET/CT SCANNER Cti Pet Systems, Inc. KPS Class II 2001-10-31
K013422 CARDIQ FUNCTION GE Medical Systems JAK Class II 2001-10-30
K013395 LIFEJET VIDEO LINK Ferrania S.P.A. LMA Class II 2001-10-30
K011265 ULTRASOUND TRANSDUCER COVER Advance Medical Designs, Inc. ITX Class II 2001-10-30
K013381 ADVANCED LUNG ANALYSIS-1 General Electric Co. JAK Class II 2001-10-26
K012491 MACHNET CAROTIDS COIL ARRAY ASSEMBLY Machnet BV MOS Class II 2001-10-24
K013290 MODIFIED 650 MAMMOGRAPHY SYSTEM Lorad, A Hologic Co. IZH Class II 2001-10-24
K012475 CAAS II QVA Pie Medical Imaging BV LLZ Class II 2001-10-24
K013279 MOSFET AUTOSENSE, MODEL TN-RD-60 Thomson & Nielsen Electronics, Ltd. IYE Class II 2001-10-18
K012522 WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL National Therapy Products, Inc. ITX Class II 2001-10-18
K002132 ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS Intelligent Instruments Pvt. , Ltd. MUJ Class II 2001-10-18
K013150 MR-GUIDE 2000 Ultraguide , Ltd. LNH Class II 2001-10-18
K012424 SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM Shimadzu Corp. JAA Class II 2001-10-18
K010032 SEED SELECTRON MODEL V. 1.0 Nucletron Corp. JAQ Class II 2001-10-17
K013322 HAC-420 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2001-10-16
K013159 HRH-63-8 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2001-10-16
K013229 LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE Ferrania USA, Inc. IXA Class II 2001-10-12
K013142 DIASUS Dynamic Imaging , Ltd. IYO Class II 2001-10-05
K013214 CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A Toshiba America Medical Systems, In.C JAK Class II 2001-10-05
K012238 DOSERIGHT Philips Medical Systems North America Co. JAK Class II 2001-10-01
K003238 SOLID STATE X-RAY IMAGING DEVICES Cares Built, Inc. MQB Class II 2001-10-01
K012227 MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 Oncology Data Systems, Inc. IYE Class II 2001-10-01
K012772 CTS-485 ULTRASOUND IMAGING SYSTEM Shantou Institute of Ultrasonic Instuments IYO Class II 2001-10-01
K011049 EXPRESSSUITE Vidar Systems Corp. LMA Class II 2001-10-01
K013138 ADC COMPACT PLUS Agfa-Gevaert AG MQB Class II 2001-09-28
K012290 RAPIDIA 3D Med Co., Ltd. LLZ Class II 2001-09-28
K012202 NUMARIS 4VA15A Siemens Medical Corp. LNH Class II 2001-09-27
K012084 SONOREAL 3D Bio Medi Com IYO Class II 2001-09-26
K012106 ACCUIMAGE SMARTGATE UPGRADE Accuimage Diagnostics Corp. JAK Class II 2001-09-25
K013099 MODIFICATION TO: QWH-420 WRIST ARRAY COIL Mri Devices Corp. MOS Class II 2001-09-25
K012970 GE SIGNA ASSET IMAGING OPTION GE Medical Systems LNH Class II 2001-09-24
K012093 AETMED IMAGE PROCESSING SOFTWARE Aetmed, S.P.A. LLZ Class II 2001-09-21
K004023 INTRA OPERATIVE RADIATION THERAPY Arplay Medical S.A. IYE Class II 2001-09-21
K012010 MODIFICATION TO LR 5200 FILM RECORDER Agfa Corp. LMC Class II 2001-09-20
K012154 AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE Aurora Imaging Technology, Inc. LNH Class II 2001-09-19
K012165 OLDELFT THORASCAN MODEL NUMBER 180T Nucletron Corp. KPR Class II 2001-09-19
K012775 GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER GE Medical Systems KPS Class II 2001-09-18
K012086 AQUARIUSNET SERVER Terarecon,Inc. LLZ Class II 2001-09-13
K012009 MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc. JAK Class II 2001-09-13
K012867 SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYN Class II 2001-09-12
K012887 SA6000II DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYO Class II 2001-09-12
K011816 MINI MULTILEAF COLLIMATOR, MODEL KMI Mrc Systems GmbH IXI Class II 2001-09-07
K012836 MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM GE Medical Systems JAK Class II 2001-09-07
K012568 GE VISION NUCLEAR MEDICINE WORKSTATION General Electric Co. KPS Class II 2001-09-06
K011763 OMNIDOS Scanditronix Medical AB IYE Class II 2001-09-05
K010621 ACCU-SPACE ABSORBABLE SEEDING SPACERS Cp Medical KXK Class II 2001-09-04
K011781 INTERCEPT-URETHRAL MICROCOIL Surgi-Vision, Inc. MOS Class II 2001-08-31
K012663 EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) Sedecal USA, Inc. IZL Class II 2001-08-31
K011427 MBI PD-103 SL; MBI PD-103 SH Mills Biopharmaceuticals, Inc. KXK Class II 2001-08-31
K012253 SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYO Class II 2001-08-30
K011949 ELK LASER IMAGER, MODEL EL-DRY 4000 Nishimoto Sangyo Co., Ltd. LMC Class II 2001-08-29
K012728 E-SCAN MRI SYSTEM Biosound Esaote, Inc. MOS Class II 2001-08-29
K012080 SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2001-08-29
K011694 VIEWSTATION Impac Medical Systems, Inc. LLZ Class II 2001-08-29
K011657 HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2001-08-27
K012560 GE LOGIQ A100 MP, MODEL 2272413 General Electric Co. IYO Class II 2001-08-23
K010772 ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM Imaging Services, Inc. JAA Class II 2001-08-23
K011604 PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI Ge Medical Systems, Inc. LNI Class II 2001-08-22
K012379 PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM Trex Enterprises Corp. IZL Class II 2001-08-16
K011608 MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL Medical Advances, Inc. MOS Class II 2001-08-14
K012289 MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) Elekta Oncology Systems, Ltd. IYE Class II 2001-08-14
K012353 HNC-127 NEUROVASCULAR ARRAY COIL Mri Devices Corp. MOS Class II 2001-08-14
K012239 MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM Hitachi Medical Corp. IYN Class II 2001-08-10
K012369 BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 Atys Medical IYN Class II 2001-08-10
K012385 HISPEED X/I SMART GANTRY OPTION Ge Medical Systems, Inc. JAK Class II 2001-08-10
K012389 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM Ge Medical Systems, Inc. KPR Class II 2001-08-10
K012155 KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS Eastman Kodak Company LLZ Class II 2001-08-10
K011024 CYBERKNIFE SYSTEM Accuray, Inc. IYE Class II 2001-08-10
K012373 LIFERAY WL CASSETTE, LIFERAY KW CASSETTE Ferrania S.P.A. IXA Class II 2001-08-09
K012313 CT COLONOGRAPHY/NAVIGATOR2 Ge Medical Systems, Inc. JAK Class II 2001-08-07
K011416 MUSCLE IMAGING SYSTEM (MIS) Millennium Magnetic Imaging, Inc. LNH Class II 2001-08-06
K011917 ADVANCED HIP ASSESSMENT SOFTWARE Ge Lunar Corp. KGI Class II 2001-08-03
K011447 IN SPACE 3D Siemens Medical Solutions USA, Inc. JAK Class II 2001-08-03
K012200 1.5T INFINITY TWINSPEED MR SYSTEM GE Medical Systems LNH Class II 2001-08-03
K003285 EXAC TRAC 2.0 (NOVALIS BODY MODULE) Brainlab AG IYE Class II 2001-07-31
K011582 QCU ANALYTICAL SOFTWARE PACKAGE Medis Medical Imaging Systems BV LLZ Class II 2001-07-31
K012099 MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES Totoku Electric Co., Ltd. LLZ Class II 2001-07-31
K012211 EFILM WORKSTATION Efilm Medical, Inc. LLZ Class II 2001-07-31
K012191 TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES Teratech Corp. IYN Class II 2001-07-26
K011332 RF-IVD WIRELESS DOSIMETER-MODEL 1133 Sun Nuclear Corp. IYE Class II 2001-07-26
K983332 NORTHEAST PROTON THERAPY CENTER Massachusetts General Hospital LHN Class II 2001-07-20
K011296 INFINION ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc. LNH Class II 2001-07-19
K011581 AMERITEK BRACHYTHERAPY TEMPLATE Amertek Medical, Inc. ITX Class II 2001-07-17
K012097 VORTEX Ultravisual Medical Systems LLZ Class II 2001-07-12
K003779 IMMOBILIZATION SYSTEM FOR ENT Arplay Medical S.A. IYE Class II 2001-07-12
K012017 VARISEED 7.0 Varian Medical Systems MUJ Class II 2001-07-12
K011155 INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S Ibt, Inc. KXK Class II 2001-07-12
K983024 PROTON THERAPY SYSTEM Ion Beam Applications S.A. LHN Class II 2001-07-12
K012072 VOXAR VC, MODEL 1.0 Voxar Limited LLZ Class II 2001-07-12
K011987 MODIFIED M-IV MAMMOGRAPHY SYSTEM Lorad, A Hologic Co. IZH Class II 2001-07-11

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