meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
24
Latest Decision
2005-11-22

Clearances · page 79 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K053010 VISTADENT AT COMPLETE, MODEL 3.1 Dentsply Intl., Inc. LLZ Class II 2005-11-22
K053043 ENCOMPASS SOFTWARE PACKAGE Toshiba America Medical Systems, In.C LLZ Class II 2005-11-18
K053009 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE Medical Systems LNH Class II 2005-11-17
K052938 CR-PRO Eradlink, Inc. MQB Class II 2005-11-17
K053042 MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE Medrad, Inc. MOS Class II 2005-11-17
K052618 IMAGECAST PACS Idx Systems Corp. LLZ Class II 2005-11-17
K053084 SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM Kontron Medical Systems Sas IYN Class II 2005-11-16
K053069 SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc. IYN Class II 2005-11-16
K052537 CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 American Medical Sales, Inc. LLZ Class II 2005-11-16
K052958 COLOR NIO 2MP, E-2320 C Barcoview LLZ Class II 2005-11-16
K053017 MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS Invivo Corporation MOS Class II 2005-11-16
K052852 SUPERDIMENSION/BRONCHUS PREMIUM Superdimension, Ltd. JAK Class II 2005-11-14
K052331 ACUSON CYPRESS ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2005-11-10
K052916 USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY Usa Instruments, Inc. MOS Class II 2005-11-09
K052978 GE 1.5T SIGNA HDE MR SYSTEM Ge Medical Systems, LLC LNH Class II 2005-11-09
K052228 SMIT SLEEVE Nucletron Corporation JAQ Class II 2005-11-09
K052987 BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC Noras Rontgen-Und Medizintechnik GmbH LNH Class II 2005-11-08
K053046 ILUMA ORTHOCAT/DENTALCAT Imtec Corp. JAK Class II 2005-11-08
K052698 MODIFICATION TO: AURORA Aurora Imaging Technology, Inc. LNH Class II 2005-11-08
K052995 ADVANTAGE WORKSTATION 4.3. GE Healthcare LLZ Class II 2005-11-08
K052545 INFINITT G3 PACS Infinitt Co., Ltd. LLZ Class II 2005-11-08
K052595 CRC 15ULTRA Capintec, Inc. JAQ Class II 2005-11-08
K052897 GE DEFINIUM AMX 700, MODEL AMX 700 General Electric Medical Systems IZL Class II 2005-11-08
K053024 SYNGO NEURO DSA CT Siemens AG JAK Class II 2005-11-04
K050296 ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems MUJ Class II 2005-11-03
K052095 MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 Konica Minolta Medical & Graphic, Inc. MQB Class II 2005-11-03
K051998 REGIUS MODEL 170 DIRECT DIGITIZER Konica Minolta Medical & Graphic, Inc. MQB Class II 2005-11-03
K052704 MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE Invivo Corp. MOS Class II 2005-11-03
K052541 MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM Avant Medical Systems KPR Class II 2005-11-03
K052827 MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS Medrad, Inc. MOS Class II 2005-11-01
K052775 SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) Siemens AG Medical Solutions LLZ Class II 2005-10-31
K052911 ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2005-10-31
K052379 MIM 3.5 (CIRCA) Mimvista Corp. LLZ Class II 2005-10-31
K052473 CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 Inter Medical Medizintechnik GmbH IYX Class I 2005-10-28
K052855 STARSPEED SERIES CT SCANNER SYSTEMS GE Healthcare JAK Class II 2005-10-28
K052895 FOURSIGHT VIEWTOOL IMAGE VIEWER Siemens Medical Solutions USA, Inc. LLZ Class II 2005-10-27
K052721 MINXRAY, MODEL HF100H+ Minxray, Inc. IZL Class II 2005-10-27
K052884 MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR Toshiba America Medical Systems, In.C OWB Class II 2005-10-26
K052361 SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM Nucletron Corporation KPQ Class II 2005-10-24
K052581 LUNAR IDXA Ge Medical Systems Ultrasound and Primary Care Dia KGI Class II 2005-10-20
K052433 PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM Bioptics, Inc. MWP Class II 2005-10-18
K052351 HDR IORT SHIELDED APPLICATOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2005-10-17
K052284 REFORMAT GATEWAY Infinitt Co., Ltd. LLZ Class II 2005-10-17
K052571 MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 Neurognostics, Inc. LNH Class II 2005-10-17
K052805 MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 Esaote, S.p.A. IYN Class II 2005-10-17
K052500 DAR-8000F Shimadzu Medical Systems IZI Class II 2005-10-17
K052497 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A Invivo Corp. MOS Class II 2005-10-12
K052621 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL Usa Instruments, Inc. MOS Class II 2005-10-07
K052341 AJEX 9015/135H PORTABLE X-RAY Jpi America, Inc. IZL Class II 2005-10-07
K052640 GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc. KPS Class II 2005-10-07
K052312 WIDE 5MP (MAMMO) LCD MONITOR SYSTEM Wide Corporation LLZ Class II 2005-10-07
K052584 1.5T 12 CHANNEL BODY ARRAY Usa Instruments, Inc. MOS Class II 2005-10-07
K052358 ETIAM STAR PACS COMPONENTS Etiam, S.A. LLZ Class II 2005-10-05
K052430 CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM Digirad Corp. KPS Class II 2005-10-04
K052585 3T HD BREAST ARRAY Usa Instruments, Inc. MOS Class II 2005-10-04
K052164 MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A Siemens Medical Solutions USA, Inc. LNH Class II 2005-10-04
K052220 IPLAN RT FIBERTRACKING Brainlab AG IYE Class II 2005-09-30
K052529 E-2320 PA S Barcoview LLZ Class II 2005-09-30
K052352 COLOR CORONIS 2MP-21 AND MFCD 2321 Barcoview LLZ Class II 2005-09-30
K052517 SITE-RITE 5 ULTRASOUND SYSTEM C.R. Bard, Inc. ITX Class II 2005-09-29
K052478 MFCD 1219, MFCD 1219 TS Barcoview LLZ Class II 2005-09-28
K052579 PORTAL GRAVITY SYSTEM Portal, Inc. LNH Class II 2005-09-27
K052434 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE Medical Systems KPS Class II 2005-09-27
K052172 HHF1 MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc. LNH Class II 2005-09-27
K052199 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) Totoku Electric Co., Ltd. LLZ Class II 2005-09-22
K052410 ACUSON SEQUOIA ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2005-09-22
K052315 SIMTEC IM-MAXX 2 OPTION Siemens Medical Solutions USA, Inc. LNH Class II 2005-09-22
K052461 SYNGO IMAGING VERSION V20A Siemens AG Medical Solutions LLZ Class II 2005-09-22
K052460 POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE Ramsoft, Inc. LLZ Class II 2005-09-21
K052441 GE LOGIQ 7 ULTRASOUND BT05 General Electric Co. IYN Class II 2005-09-21
K052293 GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM Ge Medical Systems, LLC LNH Class II 2005-09-21
K052447 SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 Analogic Corp. JAK Class II 2005-09-21
K052276 NIO 2MP-20 AND E-2620 S Barcoview LLZ Class II 2005-09-21
K052411 HIPAX MEDICAL IMAGING SOFTWARE Steinhart Medizinsysteme GmbH LLZ Class II 2005-09-21
K051494 MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 Cr Tech, Ltd. MQB Class II 2005-09-21
K052412 INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE Healthcare OWB Class II 2005-09-16
K052429 CORONIS 3MP-21 AND MFGD 3621 Barcoview LLZ Class II 2005-09-15
K052403 CORONIS 2MP-21 AND MFGD 2621 Barcoview LLZ Class II 2005-09-15
K052344 COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C Eizo Nanao Corporation LLZ Class II 2005-09-14
K052355 AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-Systems, Inc. IYO Class II 2005-09-14
K052325 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray Incorporated MUJ Class II 2005-09-14
K052345 ADVANTAGE SIM MD GE Healthcare KPQ Class II 2005-09-14
K052216 SOMATOM DEFINITION Siemens Medical Systems, Inc. JAK Class II 2005-09-08
K052260 SUPERDIMENSION/BRONCHUS 4.1 Superdimension, Ltd. JAK Class II 2005-09-08
K052337 MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 Eizo Nanao Corporation LLZ Class II 2005-09-08
K052305 MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A Siemens Medical Solutions USA, Inc. LNH Class II 2005-09-08
K052159 AIDA COMPACT II SYSTEM KARL STORZ Endoscopy-America, Inc. LLZ Class II 2005-09-07
K052024 NSTRAND IMPLANTATION KIT North American Scientific, Inc. KXK Class II 2005-09-07
K052078 ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES Philips Medical Systems Nederland B.V. LNH Class II 2005-09-07
K052076 DAR-8000I Shimadzu Medical Systems IZI Class II 2005-09-02
K052251 DRYSTAR MODEL 5500 Agfa Corporation LMC Class II 2005-08-31
K052067 DOPPLER GUIDED PROCTOSCOPE, MODEL 500H Multigon Industries, Inc. JAF Class II 2005-08-29
K052136 GR17 DIGITAL DETECTOR Anrad Corp. MQB Class II 2005-08-25
K052157 INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ Ge Medical Systems, LLC JAK Class II 2005-08-25
K052045 ACCESS BREAST COIL Confirma, Inc. MOS Class II 2005-08-24
K051853 CARDIOSTREAM SONOAIM Cardiostream, LLC LLZ Class II 2005-08-22
K051980 DVT SCANNER Imaging Sciences Intl., Inc. JAK Class II 2005-08-19
K052200 TEM 3000 HEAD COIL Mr Instruments, Inc. MOS Class II 2005-08-19
K051920 VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 Volcano Corporation IYO Class II 2005-08-19
K051305 CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 Cs Medical, LLC PSW Class II 2005-08-18

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