Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 22
- Latest Decision
- 2015-09-14
Clearances · page 47 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K151645 | MAMMOMAT Fusion | Siemens Medical Solutions USA, Inc. | MUE | Class II | 2015-09-14 |
| K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2015-09-14 |
| K151560 | QuickPlan | Siris Medical | MUJ | Class II | 2015-09-11 |
| K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets | Varian Medical Systems, Inc. | JAQ | Class II | 2015-09-11 |
| K152303 | CT Sim Laser System | Gammex, Inc. | IWE | Class I | 2015-09-11 |
| K151972 | JUSHA-C43 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2015-09-10 |
| K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | IYO | Class II | 2015-09-10 |
| K152279 | ViZion DR + Wireless | Viztek, LLC | MQB | Class II | 2015-09-10 |
| K151861 | JUSHA-C23C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2015-09-10 |
| K151668 | S-scan | Esaote, S.p.A. | LNH | Class II | 2015-09-08 |
| K141488 | CAREVIEW 1800R | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2015-09-08 |
| K152250 | SpeqRT | Signostics Limited | IYN | Class II | 2015-09-03 |
| K152396 | S12 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2015-09-03 |
| K150265 | Model 206 Electrometer/Dosimeter | Cnmc Company Incorporated | IYE | Class II | 2015-09-03 |
| K151666 | Leksell GammaPlan | Elekta Instrument AB | MUJ | Class II | 2015-09-03 |
| K142982 | OPUS 5100 Diagnostic Doppler Ultrasound System | Chang Gung Medical Technology Co., Ltd. | IYN | Class II | 2015-09-03 |
| K143586 | FACT Medical Imaging Sysytem | Dexin Medical Imaging Technology Co., Ltd. | LLZ | Class II | 2015-09-02 |
| K150239 | FibroScan | Echosens | IYO | Class II | 2015-09-01 |
| K151957 | BOX DICOM Viewer | Box, Inc. | LLZ | Class II | 2015-09-01 |
| K152164 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2015-08-28 |
| K151753 | 16 ch Tx/Rx Knee SPEEDER | Quality Electrodynamics, LLC | MOS | Class II | 2015-08-27 |
| K152165 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2015-08-26 |
| K152186 | HealthMyne PACS | Healthmyne, Inc. | LLZ | Class II | 2015-08-20 |
| K151837 | CS 3D Imaging | Trophy | LLZ | Class II | 2015-08-19 |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2015-08-19 |
| K151180 | ScandiDos Delta4 Phantom+ | Scandidos AB | IYE | Class II | 2015-08-19 |
| K151371 | Corporate Dental Imaging (CDI) Application | U.S. Army Dental Command (Dencom) | LLZ | Class II | 2015-08-19 |
| K150767 | EDOSE | Guangzhou Raydose Software Technology., LLC | IYE | Class II | 2015-08-17 |
| K151598 | VesselNavigator Rel. 1.0 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2015-08-17 |
| K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Systems | Ge Medical Systems, LLC | JAK | Class II | 2015-08-14 |
| K151533 | Respiratory Gating for Scanners | Varian Medical Systems, Inc. | JAK | Class II | 2015-08-13 |
| K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2015-08-13 |
| K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2015-08-12 |
| K151859 | Synapse Cardiovascular | Fujifilm Medical Systems U.S.A, Inc. | LLZ | Class II | 2015-08-12 |
| K150745 | syngo.CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-08-11 |
| K150757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-08-11 |
| K151850 | McKesson Cardiology | Mckesson Israel , Ltd. | LLZ | Class II | 2015-08-11 |
| K151369 | .decimal p.d | .Decimal, LLC | MUJ | Class II | 2015-08-07 |
| K150665 | Philips Spectral CT Applications | Philips Medical Systems Nethrlands BV | JAK | Class II | 2015-08-07 |
| K151657 | Shielded Applicator Set, Cervical Stop | Varian Medical Systems, Inc. | JAQ | Class II | 2015-08-07 |
| K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2015-08-07 |
| K151924 | Q-Rad Radiographic System with Auto-Tracker Option | Quantum Medical Imaging Divison of Carestream | KPR | Class II | 2015-08-07 |
| K151653 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2015-08-07 |
| K151000 | O-Arm O2 Imaging System | Medtronic, Inc. | OWB | Class II | 2015-08-06 |
| K151286 | OPTIS Integrated System Mobile Workstation | Lightlab Imaging, Inc. | NQQ | Class II | 2015-08-05 |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | IWB | Class II | 2015-08-04 |
| K150929 | CareView 1500Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2015-08-04 |
| K151219 | Models 2200DR and 1600DR Digital Stationary Radiographic Systems | Beijing Polycon Medical Engineering Company | KPR | Class II | 2015-08-04 |
| K151687 | QuantorView | 3Disc Americas | LLZ | Class II | 2015-08-03 |
| K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | LLZ | Class II | 2015-07-31 |
| K151904 | SyncVision System | Volcano Corporation | OWB | Class II | 2015-07-31 |
| K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | PGY | Class II | 2015-07-30 |
| K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | LNH | Class II | 2015-07-29 |
| K151829 | Atlas SPEEDER Header/Neck | Quality Electrodynamics, LLC | MOS | Class II | 2015-07-29 |
| K143368 | GenIQ | Ge Medical Systems, LLC | LLZ | Class II | 2015-07-29 |
| K151808 | 3D/5D Viewer | Samsung Medison Co., Ltd. | LLZ | Class II | 2015-07-29 |
| K151854 | 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display | D-View Display Technology Co., Ltd. | LLZ | Class II | 2015-07-28 |
| K151207 | Proton Immobilization Solution | Orfit Industries NV | IYE | Class II | 2015-07-28 |
| K150861 | QBit Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | IYN | Class II | 2015-07-28 |
| K151038 | EPX-Series Mobile X-ray System | Ecotron Co., Ltd. | IZL | Class II | 2015-07-24 |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2015-07-23 |
| K141720 | iuStar300 Medical Ultrasound Diagnostic System | United Imaging Systems (Beijing) Co., Ltd. | IYN | Class II | 2015-07-23 |
| K151505 | Coronis Uniti | Barco N.V. | PGY | Class II | 2015-07-17 |
| K151685 | GUA60A, GU60A-65 | Samsung Electronics Co., Ltd. | KPR | Class II | 2015-07-17 |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | Qingdao Hisense Medical Equipment Co., Ltd. | IYO | Class II | 2015-07-17 |
| K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 | Varian Medical Systems, Inc. | JAQ | Class II | 2015-07-17 |
| K143176 | UltraLinq | Ultralinq Healthcare Solutions, Inc. | LLZ | Class II | 2015-07-17 |
| K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2015-07-17 |
| K150878 | ILUMIEN OPTIS | Lightlab Imaging, Inc. | NQQ | Class II | 2015-07-15 |
| K151014 | Aura DR 43C-AG flat panel detector | Abyzr Co., Ltd. | MQB | Class II | 2015-07-13 |
| K151091 | Vitrea Software Toshiba Package, VSTP-001A | Toshibamedical Systems Corporation | LLZ | Class II | 2015-07-13 |
| K143345 | SIGNA Pioneer | Ge Healthcare Japan Corporation | LNH | Class II | 2015-07-10 |
| K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | IYN | Class II | 2015-07-09 |
| K150313 | Ablation Confirmation | Neuwave Medical, Inc. | LLZ | Class II | 2015-07-09 |
| K151438 | Dentrix Ascend Imaging | Realcloud Imaging, Inc. | LLZ | Class II | 2015-07-07 |
| K151233 | Monaco | Impac Medical Systems, Inc. | MUJ | Class II | 2015-07-07 |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | Accuray Incorporated | IYE | Class II | 2015-07-01 |
| K151485 | GENESIS | Dornier Medtech America, Inc. | JAA | Class II | 2015-06-30 |
| K151465 | AeroDR SYSTEM 2 | Konica Minolta, Inc. | MQB | Class II | 2015-06-29 |
| K142750 | JiveX | Visus Technology Transfer GmbH | LLZ | Class II | 2015-06-26 |
| K150766 | Carestream DRX-1 System | Carestream Health, Inc. | MQB | Class II | 2015-06-24 |
| K151272 | Henschke Titanium Applicator Set | Nucletron B.V. | JAQ | Class II | 2015-06-23 |
| K143020 | LiverMultiScan | Mirada Medical, Ltd. | LNH | Class II | 2015-06-23 |
| K143476 | Digi-One | Rimed , Ltd. | IYN | Class II | 2015-06-23 |
| K151419 | GF50A | Samsung Electronics Co., Ltd. | KPR | Class II | 2015-06-23 |
| K150002 | iNSIGHT Color Doppler Ultrasound System | Saset (Chengdu), Inc. | IYN | Class II | 2015-06-23 |
| K151192 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2015-06-23 |
| K151221 | Kubtec DIGIVIEW 395 | Kub Technologies, Inc. | MQB | Class II | 2015-06-23 |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | KXK | Class II | 2015-06-19 |
| K151028 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2015-06-18 |
| K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | OWB | Class II | 2015-06-18 |
| K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | NZT | Class II | 2015-06-16 |
| K150080 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2015-06-12 |
| K151238 | JUSHA-M23C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2015-06-12 |
| K150415 | NilRead | Perceptive Software | LLZ | Class II | 2015-06-12 |
| K150725 | Visaris Avanse | Visaris D.O.O. Belgrade | KPR | Class II | 2015-06-08 |
| K151060 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | IYO | Class II | 2015-06-05 |
| K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2015-06-05 |
| K150976 | Collage | Anatomage, Inc. | LLZ | Class II | 2015-06-04 |
| K150949 | FibroScan | Echosens | IYO | Class II | 2015-06-03 |
14,721 clearances in the Radiology panel. Data: openFDA.