Radiology
14,649 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (K151451) | Toshibamedical Systems Corporation | 2015-07-09 |
| Ablation Confirmation (K150313) | Neuwave Medical, Inc. | 2015-07-09 |
| Monaco (K151233) | Impac Medical Systems, Inc. | 2015-07-07 |
| Dentrix Ascend Imaging (K151438) | Realcloud Imaging, Inc. | 2015-07-07 |
| CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System (K150873) | Accuray Incorporated | 2015-07-01 |
| GENESIS (K151485) | Dornier Medtech America, Inc. | 2015-06-30 |
| AeroDR SYSTEM 2 (K151465) | Konica Minolta, Inc. | 2015-06-29 |
| JiveX (K142750) | Visus Technology Transfer GmbH | 2015-06-26 |
| Carestream DRX-1 System (K150766) | Carestream Health, Inc. | 2015-06-24 |
| Henschke Titanium Applicator Set (K151272) | Nucletron B.V. | 2015-06-23 |
| GF50A (K151419) | Samsung Electronics Co., Ltd. | 2015-06-23 |
| Kubtec DIGIVIEW 395 (K151221) | Kub Technologies, Inc. | 2015-06-23 |
| Digi-One (K143476) | Rimed , Ltd. | 2015-06-23 |
| syngo.via MI Workflows (K151192) | Siemens Medical Solutions USA, Inc. | 2015-06-23 |
| LiverMultiScan (K143020) | Mirada Medical, Ltd. | 2015-06-23 |
| iNSIGHT Color Doppler Ultrasound System (K150002) | Saset (Chengdu), Inc. | 2015-06-23 |
| SPEC Model M16 (K150895) | Source Production and Equipment Co., Inc. | 2015-06-19 |
| LOGIQ e (K151028) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-06-18 |
| XIDF-AWS801, Angio Workstation, V6.10 (K150967) | Toshibamedical Systems Corporation | 2015-06-18 |
| OARtrac System with Skin Sensors (K150719) | Radiadyne, LLC | 2015-06-16 |
| JUSHA-M23C LCD Monitor (K151238) | Nanjing Jusha Display Technology Co., Ltd. | 2015-06-12 |
| DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S (K150080) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-06-12 |
| NilRead (K150415) | Perceptive Software | 2015-06-12 |
| Visaris Avanse (K150725) | Visaris D.O.O. Belgrade | 2015-06-08 |
| Ez3D-i/E3 (K150761) | Ewoosoft Co., Ltd. | 2015-06-05 |
| Ultrasound System SONIMAGE HS1 (K151060) | Konica Minolta, Inc. | 2015-06-05 |
| Collage (K150976) | Anatomage, Inc. | 2015-06-04 |
| MR Core Software (K151115) | Vital Images, Inc. | 2015-06-03 |
| FibroScan (K150949) | Echosens | 2015-06-03 |
| PROBEAT-V (K151132) | Hitachi, Ltd., Health Care Company | 2015-06-01 |
| ICIS View (K143397) | Agfa Healthcare N.V. | 2015-06-01 |
| 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) (K151134) | Jvckenwood Corporation | 2015-05-27 |
| IntelePACS (K150707) | Intelerad Medical Systems Incorporated | 2015-05-27 |
| Centricity Universal Viewer (K150420) | GE Healthcare | 2015-05-26 |
| VentriPoint Medical System (K150628) | Ventripoint, Inc. | 2015-05-22 |
| Fine Structure Analysis(fineSA) (K150069) | Acuitas Medical , Ltd. | 2015-05-22 |
| SPINEDESIGN Spine Surgery Planning (Software Application) (K142648) | Medtronic Sofamor Danek USA, Inc. | 2015-05-22 |
| Retina Workplace (K150467) | Carl Zeiss Meditec, AG | 2015-05-21 |
| SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE (K141900) | Eckert & Ziegler Bebig GmbH | 2015-05-20 |
| E-App (K142719) | Gc Medtech, LLC | 2015-05-20 |
| Dose Calculator (K150848) | Sun Nuclear Corporation | 2015-05-20 |
| syngo.CT Dental (K150785) | Siemens Medical Solutions USA, Inc. | 2015-05-18 |
| ZONARE ZS3 Diagnostic Ultrasound System (K151175) | Zonare Medical Systems, Inc. | 2015-05-15 |
| Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways (K143294) | Toshibamedical Systems Corporation | 2015-05-15 |
| .decimal Astroid Dosimetry App (K150547) | .Decimal, Inc. | 2015-05-15 |
| Active Breathing Coordinator (K151097) | Aktina Medical Corporation | 2015-05-15 |
| Planmed Verity (K143435) | Planmed OY | 2015-05-14 |
| syngo.CT Lung CAD (K143196) | Siemens AG Medical Solutions | 2015-05-12 |
| Terason uSmart3200T Ultrasound System (K150533) | Teratech Corp. | 2015-05-09 |
| ORTHOPHOS SL (K150217) | Sirona Dental Systems GmbH | 2015-05-08 |
| Jumong Series (K150816) | Sg Healthcare Co, Ltd. | 2015-05-08 |
| MultiBand SENSE (K143606) | Philips Medical Systems Nethrlands BV | 2015-05-08 |
| VitalBeam (K150706) | Varian Medical Systems, Inc. | 2015-05-08 |
| Touch Ultrasound (K150342) | Carestream Health, Inc. | 2015-05-08 |
| 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) (K151007) | Jvckenwood Corporation | 2015-05-08 |
| VariSeed 9.0 (K150636) | Varian Medical Systems, Inc. | 2015-05-08 |
| Diagnostic X-ray System (K150663) | Osko, Inc. | 2015-05-07 |
| Acclarix Diagnostic Ultrasound System (K150999) | Edan Instruments, Inc. | 2015-05-06 |
| ILUMIEN, Drageonfly OPTIS Imaging Catheter (K150237) | Lightlab Imaging, Inc. | 2015-05-05 |
| Visage Ease Pro (K142196) | Visage Imaging GmbH | 2015-04-28 |
| S30/S40 Digital Color Doppler Ultraound System (K150045) | Sonoscape Company Limited | 2015-04-28 |
| JUSHA-M53 Medical Display (K150842) | Nanjing Jusha Display Technology Co., Ltd. | 2015-04-28 |
| syngo®.via (version VB10A) (K150843) | Siemens AG | 2015-04-24 |
| GammaBeam 500 (K150191) | Best Theratronics Limited | 2015-04-17 |
| SagiNova (K142986) | Eckert & Ziegler Bebig GmbH | 2015-04-17 |
| Vitrea CT Myocardial Perfusion (K150104) | Vital Images, Inc. | 2015-04-17 |
| Vantage Titan 1.5T, V3.1, MRT-1510 (K150427) | Toshibamedical Systems Corporation | 2015-04-17 |
| SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED (K142779) | Simpleware , Ltd. | 2015-04-17 |
| RAYSCAN A-EXPERT 3D (K142247) | Ray Co., Ltd. | 2015-04-17 |
| Exam Vue DR (K142930) | Jpi Healthcare Co, Ltd. | 2015-04-17 |
| SOMATOM Definition Flash (VA48) (K143416) | Siemens Medical Solutions USA, Inc. | 2015-04-16 |
| JUSHA-M52C Medical Display (K150746) | Nanjing Jusha Display Technology Co., Ltd. | 2015-04-14 |
| Delivery Analysis (K143269) | Accuray Incorporated | 2015-04-14 |
| HeartSee (K143664) | University of Texas Medical School AT Houston | 2015-04-14 |
| mint Lesion (K142647) | Mint Medical GmbH | 2015-04-13 |
| DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (K150204) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-04-10 |
| MDNG-3220 (Nio 3MP LED) (K150821) | Barco | 2015-04-10 |
| Kobold Ring and Tandem Applicator Set (K142330) | Kobold, LLC | 2015-04-09 |
| Vantage Titan 3T (K143008) | Toshibamedical Systems Corporation | 2015-04-09 |
| 18ch T/R Knee Coil (K150331) | Quality Electrodynamics, LLC | 2015-04-09 |
| G-scan Brio (K142421) | Esaote, S.p.A. | 2015-04-09 |
| O-MAR (K143253) | Philips Medical Systems Nederland B.V. | 2015-04-09 |
| ELIAN Digital Diagnostic X-ray System (K150506) | Osko, Inc. | 2015-04-08 |
| SOMATOM Definition AS/AS+ (K143400) | Siemens Medical Solutions USA, Inc. | 2015-04-08 |
| UltraVision 2 Diagnostic Ultrasound System (K150580) | Winprobe Corporation | 2015-04-07 |
| VitreaView (K150738) | Vital Images, Inc. | 2015-04-06 |
| Ziehm Vision RFD 3D (K142740) | Ziehm Imaging GmbH | 2015-04-06 |
| SOMATOM Definition Edge (K143401) | Siemens Medical Solutions USA, Inc. | 2015-04-06 |
| 2MP Color LCD Monitor, RadiForce RS240 (K150106) | Eizo Corporation | 2015-04-03 |
| EzDent-i /E2/Prora View (K150747) | LK Consulting Group USA, Inc. | 2015-04-02 |
| GC85A (K150165) | Samsung Electronics Co., Ltd. | 2015-04-02 |
| SpaceOAR System (DEN140030) | Augmenix, Inc. | 2015-04-01 |
| Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (K150234) | Myriad Medical, LLC | 2015-03-31 |
| Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System (K150529) | C.R. Bard, Inc. | 2015-03-30 |
| Scenium (K150192) | Siemens Medical Solutions USA, Inc. | 2015-03-29 |
| 1717SGN / 1717SCN Digital Flat Panel X-ray Detector (K150150) | Rayence Co., Ltd. | 2015-03-27 |
| Patient Positioning Devices (K142420) | Macromedics BV | 2015-03-27 |
| Mammo Workstation (K143361) | GE Healthcare | 2015-03-26 |
| FlexiMarc Marker (K142294) | Cortex Manufacturing, Inc. | 2015-03-26 |
| A35 Diagnostic Ultrasound System (K150478) | Samsung Medison Co., Ltd. | 2015-03-26 |
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