meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
2014-08-01

Clearances · page 51 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141302 VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) Vital Images, Inc. LLZ Class II 2014-08-01
K141690 JUSHA-M33C LCD MONITOR Nanjing Jusha Display Technology Co., Ltd. PGY Class II 2014-08-01
K141679 JUSHA-C61 LCD MONITOR Nanjing Jusha Display Technology Co., Ltd. PGY Class II 2014-08-01
K141684 JUSHA-C33C LCD MONITOR Nanjing Jusha Display Technology Co., Ltd. PGY Class II 2014-08-01
K141061 REMOTEYE VIEWER Neologica S.R.L. LLZ Class II 2014-08-01
K140551 PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR Perkinelmer, Inc. MQB Class II 2014-08-01
K141672 DIGIARC 100AU+ Beijing East Whale Imaging Technology Co., Ltd. OXO Class II 2014-07-31
K141475 ENDOSIZE Therenva Sas LLZ Class II 2014-07-31
K141832 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE Neocoil, LLC MOS Class II 2014-07-31
K141736 PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH MQB Class II 2014-07-25
K141675 VOLUSON P6, VOLUSON P8 GE Healthcare IYN Class II 2014-07-25
K133670 HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE Neocoil, LLC LNH Class II 2014-07-24
K133535 INFX-8000V, V5.30 Toshibamedical Systems Corporation OWB Class II 2014-07-23
K141652 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE Cedars-Sinai Medical Center KPS Class II 2014-07-22
K141154 OARTRAC SYSTEM Radiadyne NZT Class II 2014-07-22
K141639 VOLUSON S6, VOLUSON S8 GE Healthcare IYN Class II 2014-07-18
K141641 ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM Zonare Medical Systems, Inc. IYN Class II 2014-07-18
K140897 SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL Siemens Medical Solutions USA, Inc. LLZ Class II 2014-07-18
K140825 DELWORKS DR SYSTEM Del Medical, Inc. MQB Class II 2014-07-17
K141566 SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC Rayence Co., Ltd. MQB Class II 2014-07-16
K141563 SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC Rayence Co., Ltd. MQB Class II 2014-07-16
K140998 PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL Quality Electrodynamics, LLC MOS Class II 2014-07-11
K141486 MYLABSIX ULTRASOUND SYSTEM Esaote Europe B.V. IYN Class II 2014-07-11
K141554 ESIE APPS SUITE Siemens Medical Solutions USA, Inc. LLZ Class II 2014-07-11
K141334 REUSABLE GUIDE Koelis ITX Class II 2014-07-11
K132919 GANTRY BEAM LINE Ion Beam Applications S.A. LHN Class II 2014-07-10
K133819 VERADIUS Philips Medical Systems Nederland B.V. OWB Class II 2014-07-10
K131601 DELL U3014 WITH QUBYX PERFECTLUM BUNDLE Qubyx Limited PGY Class II 2014-07-07
K133648 SYNGO, CT DUAL ENERGY Siemens Medical Solutions USA, Inc. JAK Class II 2014-07-07
K140869 DCAS I Gp&P Co., Ltd. LLZ Class II 2014-07-03
K140909 MCKESSON RADIOLOGY Mckesson Medical Imaging Company LLZ Class II 2014-07-02
K141620 RS80A DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2014-07-02
K141556 AVREO INTERWORKS SYSTEM Avreo, Inc. LLZ Class II 2014-07-02
K141369 VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2014-07-02
K140849 ISOSEED Eckert & Ziegler Bebig GmbH KXK Class II 2014-07-02
K133693 DIGITAL RADIOGRAPHY CXDI-401C WIRELESS Canon, Inc. MQB Class II 2014-07-01
K141428 MDMC-12133 Barco N.V. PGY Class II 2014-06-27
K140823 PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER Varian Medical Systems, Inc. IYE Class II 2014-06-27
K141413 CRC PC WITH SMART CHAMBER Capintec, Inc. KPT Class II 2014-06-27
K140819 SURGICAL NAVIGATION ADVANCED PLATFORM Surgical Theater, LLC LLZ Class II 2014-06-27
K133901 PARI-PATH SURGICAL NAVIGATION SYSTEM Paritic, Inc. JAK Class II 2014-06-27
K141346 SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD Sony Electronics, Inc. LMC Class II 2014-06-26
K140803 LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM Nucletron B.V. JAQ Class II 2014-06-26
K141454 SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD Sony Electronics, Inc. LMC Class II 2014-06-26
K133848 RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK Heartvista, Inc. LNH Class II 2014-06-25
K140660 MOBIUS3D Mobius Medical Systems, LP IYE Class II 2014-06-24
K141199 QUENTRY DOSE REVIEW Brainlab AG LLZ Class II 2014-06-20
K141329 RADSPA Telerad Tech Private Limited LLZ Class II 2014-06-20
K133646 ADMIRE Siemens Medical Systems, Inc. JAK Class II 2014-06-20
K130581 KONIX STERILE GEL Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa MUI Class II 2014-06-18
K132289 GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM Gemss Medical Systems Co., Ltd. JAA Class II 2014-06-16
K140443 ARIETTA 60/ARIETTAS60/ARIETTAV60 Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical IYN Class II 2014-06-16
K140713 PLANMECA ROMEXIS Planmeca Oy LLZ Class II 2014-06-16
K133553 KALARE Toshiba America Medical Systems, In.C JAA Class II 2014-06-13
K132816 ONCENTRA BRACHY Nucletron B.V. MUJ Class II 2014-06-13
K140960 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Hologic, Inc. LLZ Class II 2014-06-13
K140666 MR ELASTOGRAPHY Philips Medical Systems Nederland B.V. LNH Class II 2014-06-13
K132524 CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION Philips Medical Systems JAK Class II 2014-06-13
K133098 SENYINT PACS Dalian Senyint Digital Medical System Co., Ltd. LLZ Class II 2014-06-13
K141381 DURADIAGNOST Philips Healthcare (Suzhou) Co., Ltd. KPR Class II 2014-06-12
K140854 INTRA-OPERATIVE ULTRASOUND TRANSDUCER Hitachi Aloka Medical, Ltd. ITX Class II 2014-06-11
K140651 CELESTEION, PCA-9000A/2 Toshibamedical Systems Corporation KPS Class II 2014-06-11
K140996 MAMMI General Equipment For Medical Imaging (Oncovision- KPS Class II 2014-06-11
K140138 HEARTNAVIGATOR RELEASE 2.0 Philips Medical Systems Nederland B.V. OWB Class II 2014-06-10
K141192 DR 400 Agfa Healthcare N.V. MQB Class II 2014-06-06
K140434 MEDICAD CLASSIC Hectec GmbH LLZ Class II 2014-06-05
K141261 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE Healthcare IYN Class II 2014-06-05
K140683 0180 INTUITION, 0072 PRECISION Arcoma AB KPR Class II 2014-06-03
K140337 BRIGHTMATTER PLANNING SOFTWARE Synaptive Medical, Inc. LLZ Class II 2014-06-02
K140364 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE Chison Medical Imaging Co., Ltd. IYN Class II 2014-06-02
K140428 ULTRASOUND SCANNER SYSTEM BK2300 B-K Medical Aps IYO Class II 2014-05-30
K140773 TERASON USMART3300 ULTRASOUND SYSTEM Teratech Corp. IYN Class II 2014-05-30
K140326 XGEO GF50 Samsung Electronics Co., Ltd. KPR Class II 2014-05-29
K140334 XGEO GC80 Samsung Electronics Co., Ltd. KPR Class II 2014-05-28
K140139 CLEARVIEWHD Clearview Diagnostics, Inc. LLZ Class II 2014-05-28
K140332 XGEO GU60A Samsung Electronics Co., Ltd. KPR Class II 2014-05-28
K140729 APLIO ARTIDA, V3.2 Toshiba America Medical Systems, In.C IYN Class II 2014-05-23
K141067 VIVID T8/VIVID T8 PRO GE Healthcare IYN Class II 2014-05-23
K132684 MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) Medecom Sarl LLZ Class II 2014-05-23
K132108 MAXIO Perfint Healthcare Pvt, Ltd. JAK Class II 2014-05-19
K140693 VSCAN WITH DUAL PROBE Ge Medical Sysyems Ultrasound & Primary Care Diagn IYN Class II 2014-05-16
K141093 6VT-D ULTRASOUND TRANSDUCER Ge Vingmed Ultrasound AS ITX Class II 2014-05-15
K140187 RAY STATION Raysearch Laboratories AB MUJ Class II 2014-05-15
K140235 XGEO GR40CW Samsung Electronics Co., Ltd. MQB Class II 2014-05-15
K133664 ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS Ge Medical Systems Ultrasound & Primary Care Diagn KGI Class II 2014-05-15
K133620 CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM Imaging Sciences International OAS Class II 2014-05-14
K141010 M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2014-05-14
K140395 VITREA IMAGE DENOISING SOFTWARE Vital Images, Inc. LLZ Class II 2014-05-13
K140056 DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A Rayence Co., Ltd. MQB Class II 2014-05-13
K140060 DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A Rayence Co., Ltd. MQB Class II 2014-05-13
K140606 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL Resonance Innovations, LLC MOS Class II 2014-05-12
K133565 LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB IWB Class II 2014-05-09
K140206 SCINTILLATION GAMMA CAMERA Ddd-Diagnostic A/S KPS Class II 2014-05-08
K140269 HERMES MEDICAL IMAGING SUITE V5.4 Hermes Medical Solutions AB KPS Class II 2014-05-08
K140252 16 CH MULTIPURPOSE COIL VARIETY Noras Rontgen-Und Medizintechnik GmbH MOS Class II 2014-05-08
K140899 HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM Halo Medical Technologies, LLC IYO Class II 2014-05-05
K140856 BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS C.R. Bard, Inc. KXK Class II 2014-05-02
K132027 OEC 9800 PLUS Ge Oec Medical Systems, Inc. OWB Class II 2014-05-01
K140959 ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. IYN Class II 2014-04-30
K133590 SOMATOM PERSPECTIVE Siemens Medical Solutions USA, Inc. JAK Class II 2014-04-30

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